Efficacy of Novel Topical Liposomal Formulation of Cyclosporine in Mild to Moderate Stable Plaque Psoriasis: A Randomized Clinical Trial. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO‐ABLE study Real‐life effectiveness of once‐daily calcipotriol and betamethasone dipropionate gel vs. ointment formulations in psoriasis vulgaris: final analysis of the 52‐week PRO‐long study Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris – A randomized phase II study Efficacy of an Innovative Aerosol Foam Formulation of Fixed Combination Calcipotriol plus Betamethasone Dipropionate in Patients with Psoriasis Vulgaris Real-life effectiveness of once-daily calcipotriol and betamethasone dipropionate gel vs. ointment formulations in psoriasis vulgaris: 4- and 12-week interim results from the PRO-long study. DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray, Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis. Medication formulation affects quality of life: a randomized single-blind study of clobetasol propionate foam 0.05% compared with a combined program of clobetasol cream 0.05% and solution 0.05% for the treatment of psoriasis. Clobetasol propionate lotion in the treatment of moderate to severe plaque-type psoriasis. Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. Clobetasol propionate foam 0.05%: a novel vehicle with enhanced delivery. Short-term safety assessment of clobetasol propionate 0.05% shampoo: hypothalamic-pituitary-adrenal axis suppression, atrophogenicity, and ocular safety in subjects with scalp psoriasis. Calcipotriol ointment versus cream in psoriasis vulgaris. Efficacy and Safety of the Betamethasone Valerate 0.1% Plaster in Mild-to-Moderate Chronic Plaque Psoriasis Different treatment outcomes with different formulations of clobetasol propionate 0.05% for the treatment of plaque psoriasis Clobetasol propionate lotion, an efficient and safe alternative to clobetasol propionate emollient cream in subjects with moderate to severe plaque‐type psoriasis
IMPORTANCE Attempts to use topical cyclosporine in treatment of psoriasis have failed because of unfavorable physicochemical properties and inappropriate formulation design of the conventional dosage forms . OBJECTIVE To evaluate the efficacy of topical cyclosporine using liposomal nanocarriers ( lipogel ) in limited chronic plaque psoriasis . DESIGN , SETTING , AND , PARTICIPANTS A single-center r and omized clinical trial was conducted using a 3-arm parallel group , double-blind , vehicle and active comparator design and included 38 patients with chronic plaque psoriasis measuring less than or equal to 100 cm2 performed in a tertiary care hospital . INTERVENTIONS In the first arm , a total of 24 patients were r and omized to receive either cyclosporine lipogel , 2.0 % weight by weight ( w/w ) , or placebo lipogel . In the second arm , 7 patients were r and omized to receive cyclosporine lipogel , 2.0 % , or conventional cyclosporine cream , 2.0 % w/w . The third arm comprised 7 patients r and omized with cyclosporine lipogel , 2.0 % or st and ard clobetasol propionate cream , 0.05 % w/w . Patients were examined twice weekly for 14 weeks , or until total lesional clearance was observed , whichever was earlier . MAIN OUTCOMES AND MEASURES The primary outcome measure was the dermatological sum score ( DSS ) assessing erythema , scaling , and plaque elevation on a 4-point scale ( 0 , absent ; 1 , minimal ; 2 , moderate ; 3 , severe ) . RESULTS In 38 patients ( 23 men and 15 women with a mean [ SD ] age range from 35 [ 8 ] to 40 [ 13 ] years ) , a 19 % decrease in DSS score from a mean ( SD ) of 8.45 ( 0.67 ) to 6.82 ( 0.77 ) compared with baseline was observed after 2 weeks of treatment with cyclosporine lipogel , 2.0 % w/w ( P < .001 ; 95 % CI , 13.77 - 24.51 ) in 59 % of psoriasis lesional sites . At the end of the eighth week , a significant reduction ( approximately 83 % ) in DSS was seen in all sites treated with cyclosporine lipogel , ( P < .001 ; 95 % CI , 77.48 - 88.22 ) . At the end of the study period , complete clearance ( ie , DSS = 0 ) was observed in 16 ( 41 % ) psoriasis lesional sites treated with cyclosporine lipogel , 85.7 % of sites treated with clobetasol propionate cream , and none of the sites treated with conventional cyclosporine cream or placebo gel . CONCLUSIONS AND RELEVANCE Topical liposomal formulation of cyclosporine , 2.0 % w/w , is effective in treatment of limited chronic plaque psoriasis  with a satisfactory safety profile . Future clinical trials should assess liposomal cyclosporine in larger study population s. TRIAL REGISTRATION Clinical Trials Registry-India Identifier : CTRI/2011/12/002307 Abstract Background Fixed combination calcipotriol 50 μg/g ( Cal ) plus betamethasone 0.5 mg/g ( BD ) foam has been developed as a new treatment option for patients with psoriasis . Methods The r and omized , parallel‐group , investigator‐blinded Phase III , 12‐week PSO‐ABLE study compared the efficacy and safety of Cal/BD foam with Cal/BD gel .  Patients aged ≥18 years with mild‐to‐severe psoriasis were r and omized 4:4:1:1 to once‐daily Cal/BD foam , Cal/BD gel , foam vehicle or gel vehicle ( NCT02132936 ) . The primary efficacy endpoint was the proportion of patients who were clear/almost clear with a ≥ 2 grade improvement according to the physician 's global assessment of disease severity ( i.e. treatment success ) at week 4 for Cal/BD foam vs. week 8 for Cal/BD gel . Secondary efficacy endpoints included : proportion of patients achieving at least a 75 % reduction in modified psoriasis area and severity index ( mPASI75 ) , and time to treatment success ( TTTS ) . Safety was monitored throughout . Results A total of 463 patients were r and omized : Cal/BD foam ( n = 185 ) , Cal/BD gel ( n = 188 ) , foam vehicle ( n = 47 ) , gel vehicle ( n = 43 ) ; overall completion rate was 90 % . Cal/BD foam achieved higher treatment success rates ( 38 % vs. 22 % ; P < 0.001 ) and mPASI75 ( 52 % vs. 35 % ; P < 0.001 ) by week 4 than Cal/BD gel by week 8 . Median TTTS with Cal/BD foam was 6 weeks ; this could not be determined for Cal/BD gel as 50 % treatment success was not achieved ( P < 0.001 ) . Adverse drug reactions were reported in 14 ( 7.6 % ) Cal/BD aerosol foam patients and 7 ( 3.7 % ) Cal/BD gel patients ; all were single events except for itch with Cal/BD aerosol foam ( n = 5 ; 2.7 % ) and worsening psoriasis with Cal/BD gel ( n = 3 ; 1.6 % ) . Conclusion Cal/BD aerosol foam showed significantly greater efficacy after 4 weeks , than 8 weeks of treatment with Cal/BD gel , with similar tolerability Abstract Background Topical therapies are the mainstay of treatment for psoriasis vulgaris . The fixed combination of calcipotriol ( Cal ) 50 μg/g plus betamethasone 0.5 mg/g ( as dipropionate ; BD ) is a first‐line topical treatment and available as a gel or ointment . The use of these fixed combination products was compared in PRO‐long , a long‐term noninterventional study , for which interim results ( 4 and 12 weeks ) have previously been reported . Objective To describe and compare patients ’ perspectives on the fixed combination gel and ointment formulations ; to include efficacy , adherence behaviour , treatment satisfaction and health‐related quality of life ( HRQoL ) aspects during long‐term real‐life psoriasis management . Methods PRO‐long was a multicentre , prospect i ve , observational , 52‐week study of patients prescribed fixed combination Cal/BD gel or ointment in clinical practice . For final analysis the following were assessed at weeks 24 , 36 and 52 : differences in the proportion of patients with ‘ mild’/‘very mild ’ disease according to patient 's global assessment of disease severity , adherence behaviour , treatment satisfaction ( nine‐item treatment satisfaction question naire for medication ) and HRQoL ( Skindex‐29 ) . Results Patients ( n = 328 ) were prescribed once‐daily Cal/BD gel ( n = 152 ) or ointment ( n = 176 ) . At week 52 , a higher proportion of patients reported that the severity of their psoriasis was ‘ mild’/‘very mild ’ vs. baseline ( gel : 60.2 vs. 47.1 % ; ointment : 58.8 vs. 42.4 % ) , with greater treatment satisfaction reported in patients using gel vs. those using ointment . A higher proportion of patients found the gel ‘ easy ’ to use compared with the ointment ( 66.7 vs. 45.2 % ) . Daily application of treatment took ≤5 min for 86.1 % of patients using gel and 71.0 % of patients using ointment . Conclusion This real‐life study has demonstrated similar effectiveness between the Cal/BD formulations . However , over a 52‐week treatment period , patients reported greater treatment satisfaction with the gel , which was considered easier to use , faster to apply and overall a more convenient product Abstract Background : An aerosol foam formulation of fixed combination calcipotriene 0.005 % ( as hydrate ; Cal ) plus betamethasone dipropionate 0.064 % ( BD ) was developed to improve psoriasis treatment . Objectives : To compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks . Methods : In this Phase II , multicenter , investigator-blind , 4-week trial , adult patients with psoriasis vulgaris were r and omized to Cal/BD aerosol foam , Cal/BD ointment , aerosol foam vehicle or ointment vehicle ( 3:3:1:1 ) . The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success ( clear or almost clear with at least a two-step improvement ) according to the physician ’s global assessment of disease severity . Results : In total , 376 patients were r and omized . At week 4 , significantly more patients using Cal/BD aerosol foam achieved treatment success ( 54.6 % versus 43.0 % [ ointment ] ; p = 0.025 ) ; mean modified ( excluding the head , which was not treated ) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment ( mean difference –0.6 ; p = 0.005 ) . Rapid , continuous itch relief occurred with both active treatments . One adverse drug reaction was reported with Cal/BD aerosol foam ( application site itch ) . Conclusions : Cal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment Background and Objective The antipsoriatic effect of an innovative aerosol foam formulation of fixed combination calcipotriol 50 μg/g ( as hydrate ; Cal ) and betamethasone 0.5 mg/g ( as dipropionate ; BD ) was explored in order to compare the effect with that of the first-line treatment Cal/BD ointment . Methods This was a Phase IIa , single-centre , investigator-blinded , exploratory study , with intra-individual comparison using a modified psoriasis plaque test . Patients were treated once daily ( 6 days/week ) for 4 weeks with Cal/BD foam , Cal/BD ointment , BD foam and Cal/BD foam vehicle , r and omized to four plaque test sites ( 5 cm2 each ) . The primary efficacy endpoint was change in total clinical score ( TCS ; sum of erythema , scaling and lesional thickness ) . Secondary endpoints included ultrasonographic changes in total skin thickness and echo-poor b and thickness , and adverse events . Results Twenty-four patients , median age 52.5 years ( range 21–75 ) , completed this study . At week 4 , test sites treated with Cal/BD foam had a significantly greater decrease in mean ( ±SD ) TCS ( −6.00 ± 1.27 ) versus those treated with Cal/BD ointment ( −5.25 ± 1.78 ; difference −0.75 ; 95 % CI −1.46 to −0.04 ; p = 0.038 ) , BD foam ( −4.96 ± 1.85 ; difference −1.04 ; 95 % CI −1.75 to −0.33 ; p = 0.005 ) or foam vehicle ( −1.88 ± 1.12 ; difference −4.13 ; 95 % CI −4.83 to −3.42 ; p < 0.001 ) . Total skin thickness and echo-poor b and thickness of Cal/BD foam-treated sites were reduced to a greater extent than those treated with comparators . Eleven patients reported 17 adverse events , the most frequent being headache ( five patients ) . There were no lesional/perilesional adverse events or adverse drug-related events . Conclusions Cal/BD foam demonstrated a significant improvement in antipsoriatic effect over Cal/BD ointment , BD foam and foam vehicle alone BACKGROUND Psoriasis is most often treated using topical therapies such as the once-daily fixed combination of calcipotriol and betamethasone dipropionate , which is available as a gel and an ointment . To date , there have been no direct comparisons of patient perspectives on the two formulations . OBJECTIVE To describe and compare patients ' perspectives on calcipotriol and betamethasone gel and ointment formulations , including real-life effectiveness , adherence behaviour , treatment satisfaction and health-related quality of life ( QoL ) , during long-term psoriasis vulgaris management , according to interim findings from the PRO-long study . METHODS PRO-long is a multicentre , prospect i ve , observational , 52-week cohort study in patients prescribed fixed-combination calcipotriol ( 50 μg/g ) and betamethasone ( 0.5 mg/g ; as dipropionate ) gel or ointment for long-term psoriasis management . Difference in effectiveness at 4 and 12 weeks was assessed by comparing the proportion of patients with controlled ( mild or very mild ) disease , according to the Patient 's Global Assessment . Additional patient question naires were used to assess adherence behaviour , treatment satisfaction ( nine-item Treatment Satisfaction Question naire for Medication ) and health-related QoL ( Skindex-29 ) . RESULTS A total of 156 patients were included in the analysis . In single items of the adherence behaviour and treatment satisfaction question naires , patients preferred the gel over the ointment as convenient , easy to use and fast to apply . Post hoc analysis demonstrated significant differences between gel and ointment for convenience and application time . More patients had controlled disease at week 12 with gel ( 71.9 % ) vs. ointment ( 65.7 % ) ; however , the difference was not statistically significant ( primary end point ; P = 0.40 ) . CONCLUSION This interim analysis supports fixed-combination calcipotriol and betamethasone gel as more convenient , easier to use and faster to apply than the ointment formulation in real-life conditions according to patients with psoriasis vulgaris . Furthermore , a numerical difference in patient-reported real-life effectiveness was seen in favour of the gel , although this was not statistically significant BACKGROUND A novel 0.05 % betamethasone dipropionate emollient spray ( DFD-01 ) was formulated to optimize penetration of steroid to the epidermal layers affected by psoriasis . OBJECTIVE To compare the efficacy and safety of medium potency DFD-01 with super potent augmented betamethasone dipropionate 0.05 % lotion ( Diprolene ) for the topical treatment of moderate plaque psoriasis . METHODS Adults with moderate plaque psoriasis ( Investigator Global Assessment [IGA]=3 ; 10 - 20 % BSA ) were r and omized 2:1:1  to DFD-01 , Diprolene , or Vehicle . Products were applied twice daily to affected areas for 14 days . Treatment success was defined as IGA=0 or 1 and ≥ 2- grade improvement from baseline . IGA and target lesion Total Sign Score ( TSS ; sum of erythema , scaling , and plaque elevation scores ) were assessed at baseline and at days 4 , 8 , and 15 . Adverse events ( AEs ) were recorded . RESULTS 351 subjects with moderate psoriasis were r and omized  to DFD-01 ( n=174 ) , Diprolene ( n=90 ) , or Vehicle ( n=87 ) . Mean BSA was 13 - 14 % . Treatment success was achieved in 19.0 % DFD-01 , 18.9 % Diprolene , and 2.3 % Vehicle ( P<0.001 DFD-01 vs Vehicle ) at day 15 . Treatment success at day 8 was 10 % DFD-01 , 6.7 % Diprolene , and 1.2 % Vehicle ( P=0.003 DFD-01 vs Vehicle ) . TSS was significantly reduced with DFD-01 compared with Vehicle at days 4 , 8 , and 15 ( P ≤ 0.006 ) and compared with Diprolene at day 4 ( P=0.010 ) . DFD-01  relieved signs of erythema and scaling earlier than Diprolene or Vehicle , showing significant improvements on day 4 ( P ≤ 0.048 ) . All products were well tolerated . Significantly more burning/stinging was reported with Diprolene than DFD-01 ( 13.6 % vs 4.1 % , P=0.006 ) . CONCLUSION Medium potency DFD-01 was efficacious for the treatment of moderate psoriasis . DFD-01 demonstrated similar efficacy to super potent Diprolene lotion . Results at 4 and 8 days indicate that DFD-01 shows early improvement in some subjects . DFD-01 was well tolerated and had an excellent safety profile For topical medications commonly used to treat dermatologic conditions , outcomes may be affected by the choice of delivery vehicles . The aim of this study was to compare quality of life ( QOL ) , effectiveness , user satisfaction , and cost-effectiveness of 2 clobetasol regimens for the treatment of psoriasis over 14 days . In a single-blind design , 32 patients r and omized into 2 groups applied either clobetasol foam 0.05 % to the skin and scalp or combination clobetasol cream 0.05 % to the skin and clobetasol solution 0.05 % to the scalp . Psoriasis severity was measured using the st and ardized Psoriasis Area and Severity Index ( PASI ) and self-administered PASI ( SAPASI ) . QOL was assessed via the EuroQoL-5D ( EQ-5D ) question naire and Dermatology Life Quality Index ( DLQI ) . Cost-effectiveness was measured by the amount of medication used per body surface area ( BSA ) treated and by cost per point improvement in PASI score . In this study , a foam formulation performed better than a cream/solution combination by several measures . A greater absolute improvement in psoriasis severity was seen in the group using the foam than in the group using the cream/solution ( mean decrease in PASI=5.0 vs 3.3 , P=.05 ) . The PASI score in the foam group decreased by 41 % versus 35 % in the cream/solution group ( P=.17 ) . In scalp psoriasis , the group using the foam had greater improvement in both absolute ( P=.03 ) and percentage ( P=.03 ) terms and than the solution group . When measuring global QOL , foam users had a significantly greater increase in EQ-5D than those using the cream/solution in absolute ( P=.05 , P=.02 ) and percentage ( P=.04 , P=.02 ) terms ( first and second survey components , respectively ) . Differences in improvement of skin-specific QOL , quantified by DLQI scores between groups , were suggested but not statistically significant . Patients using foam spent less time applying medication compared with previous topical medications ( P<.001 ) . No significant difference in cost was appreciated between foam and cream/solution over the period after controlling for BSA ( 8.18 dollars vs 7.05 dollars per percentage BSA affected , P=.30 ) Owing to its anti-inflammatory , antipruritic , vasoconstrictive , and immune-modulating properties , clobetasol propionate is used to treat psoriasis . This study was conducted to evaluate the efficacy , safety , and cosmetic acceptability of clobetasol propionate lotion compared with its vehicle and with clobetasol propionate cream in the treatment of moderate to severe plaque-type psoriasis . A total of 222 patients were treated . After 4 weeks of treatment , clobetasol propionate lotion was more efficient than vehicle lotion and of equivalent efficacy as clobetasol propionate cream .  Cosmetic acceptability was significantly better with clobetasol propionate lotion than with clobetasol propionate cream . Clobetasol propionate lotion was efficient , safe , and well tolerated and offers a significantly higher cosmetic advantage in the treatment of moderate to severe plaque-type psoriasis compared with clobetasol propionate cream BACKGROUND Available psoriasis surveys offer valuable information about psoriasis and psoriatic arthritis ( PsA ) , but are limited by methodology or enrollment requirements . OBJECTIVE To further the underst and ing of the unmet needs of psoriasis and PsA patients . METHODS This was a large , multinational , population -based survey of psoriasis and /or PsA patients in North America and Europe . Patients were selected by list-assisted r and om digit dialing and did not have to currently be under the care of a health care provider , a patient organization member , or receiving treatment ; 139,948 households were screened and 3426 patients completed the survey . RESULTS The prevalence of psoriasis/PsA ranged from 1.4 % to 3.3 % ; 79 % had psoriasis alone and 21 % had PsA. When rating disease severity at its worst , 27 % ( psoriasis ) and 53 % ( PsA ± psoriasis ) of patients rated it as severe . Psoriasis patients indicated that their most bothersome signs or symptoms were itching ( 43 % ) , scales ( 23 % ) , and flaking ( 20 % ) . Of psoriasis patients , 45 % had not seen a physician in a year ; > 80 % of psoriasis patients with ≥ 4 palms body surface area and 59 % of PsA patients were receiving no treatment or topical treatment only . Of patients who had received oral or biologic therapy , 57 % and 45 % , respectively , discontinued therapy , most often for safety/tolerability reasons and a lack/loss of efficacy . LIMITATIONS The survey lacked a control group , did not account for ethnic and health care system differences across countries , and was limited by factors associated with any patient survey , including accurate recall and interpretation of questions . CONCLUSIONS Several identified unmet needs warrant additional attention and action , including improved severity assessment , PsA screening , patient awareness , and treatment options One hundred and eighty-eight subjects with psoriasis of the scalp voluntarily participated in this multicenter , r and omized , double-blind , active , and placebo-controlled study to evaluate the safety and efficacy of clobetasol propionate foam 0.05 % ( CP foam ) relative to clobetasol propionate solution 0.05 % ( CP solution , Temovate ® scalp application ) . Adult male and female subjects with moderate to severe disease were assigned to one of four treatment groups in a 2 : 1 : 2 : 1 ratio ( CP foam : placebo foam : CP solution : placebo solution ) . Moderate to severe disease was defined as involvement of at least 10 % of the scalp and a minimum score of 2 ( 0 , none ; 1 , mild ; 2 , moderate ; 3 , severe ; 4 , very severe ) for each of the primary signs of psoriasis ( erythema , scaling , plaque thickness ) . Subjects applied study medication to the entire scalp twice daily for 14 consecutive days and were required to use DHS shampoo . No other therapy to the scalp was allowed . Pruritus , scaling , erythema , and plaque thickness were evaluated on days 0 , 7 , and 15 , and after 2 weeks off treatment on day 28 . In addition , both the investigator and subject evaluated the global response to treatment at days 15 and 28 using a seven-point grading scale ( completely clear , almost clear , marked improvement , moderate improvement , slight improvement , no change , or worse ) . The number of subjects who were ‘ ‘ completely clear ’ ' or ‘ ‘ almost clear ’ ' ( > 90 % clearing ) were lumped together to determine treatment success . Safety was assessed via st and ard clinical laboratory panels ( chemistry , hematology , urinalysis ) , physical examination , vital signs , and reported adverse events . In addition to the clinical study , the potency of CP foam relative to five other dosage forms of CP , as well as to betamethasone valerate lotion 0.1 % , was determined in 24 healthy male and female subjects using a modification of the new vasoconstrictor procedure . 1Products were r and omly applied to 3.14 cm 2sites on the ventral forearms at a dose of 10 μL , covered with a nonocclusive guard , then removed after 3 h with dry , cotton swabs . Skin color was measured at − 1 , 1 , 4 , 8 , 12 , 24 , and 30 h using a chromameter ( Minolta , Ramsey , NJ ) . Vasoconstrictor potency was assessed from the area-under-the-skin-blanching curve ( AUC ) using the a * scale output of the chromameter . The percutaneous absorption of CP from both the foam and solution formulations was determined using the cadaver skin assay . 2Each product was applied to multiple sections of skin at a dose of 6–8 mg/cm 2 , and the solution bathing the dermis was sample d at intervals and analyzed for CP content by high performance liquid chromatography . Investigators : Edwin A. Bronsky , md , Intermountain Clinical Research , Salt Lake City , UT ; Frank E. Dunlap , md , Argus Research , Inc. , Tuscon , AZ ; Holly B. Faust , md , Indiana University , Indianapolis , IN ; David P. Fivenson , md , Henry Ford Hospital , Detroit , MI ; Alan M. Heller , md , San Jose Clinical Research , San Jose , CA ; Paul A. Lehman , MS , University of Arkansas for Medical Sciences , Little Rock , AR ; Dale E. Martin , md , Skin Surgery and Skin Tumor Medical Group of San Diego , San Diego , CA ; Bruce H. Miller , md , Dermatology Associates Research Center , Portl and , OR ; S. David Miller , md , New Engl and Research Center , North Dartmouth , MA ; Jennie J. Muglia , md , Rhode Isl and Hospital , Providence , RI ; Toivo E. Rist , md , Dermatology Associates of Knoxville , Knoxville , TN ; Ronald C. Savin , md , Savin Dermatology Center , New Haven , CT ; Linda F. Stein , md , Henry Ford Hospital , Detroit , MI ; Kenneth J. Washenik , md , ph d , NYU Medical Center , New York , Clobetasol propionate is known to be a very effective treatment for psoriasis ; however , its use is limited by potent corticosteroid class related side effects such as hypothalamic-pituitary-adrenal ( HPA ) axis suppression and atrophogenicity . The aim of this single-center , parallel group , r and omized study was to assess the HPA axis suppression potential , atrophogenicity , and ocular tolerability of clobetasol propionate shampoo in 26 patients with scalp psoriasis . Suitable subjects were treated once daily for 4 weeks with clobetasol propionate shampoo , to be rinsed off after 15 minutes or with a leave-on clobetasol propionate gel . The study demonstrated that clobetasol propionate shampoo did not lead to HPA axis suppression or to skin atrophy . Conversely , the gel led to HPA axis suppression and a decrease in skin thickness . Neither formulation had an impact on ocular safety . Despite the short contact application time , the clobetasol propionate shampoo provides similar efficacy results to the gel Psoriasis is a multifactorial , chronically relapsing , inflammatory skin disease occurring in 1 - 3 % of the world 's population . Vitamin D3 analogs have effects on proliferation and differentiation , as well as on the infiltration and activation of neutrophils and immunocytes in psoriatic skin lesions . This study aims to assess the efficacy and safety of topical calcipotriol and to compare ointment and cream formulations in the treatment of psoriasis vulgaris . A total of 41 patients with mild to moderate psoriasis vulgaris ( 18 men and 23 women aged between 5 and 63 years ) were enrolled in the study . Each patient was instructed to apply the treatment twice daily over the psoriatic lesions . Routine blood tests and serum calcium were performed prior to and at the end of treatment . Treatment assessment was carried out on weeks 2 , 4 and 6 and was based on the Psoriasis Area and Severity Index ( PASI ) score . Of the 41 patients included in our study , only 29 completed the treatment course . Their PASI before treatment ranged from 1.2 to 43 ( mean : 12.1 ) . Both groups , calcipotriol 50 microg/g ointment ( 11 patients ) and calcipotriol 50 microg/g cream ( 18 patients ) showed time-dependent improvement and after 6 weeks there was excellent improvement with a marked reduction in the total mean PASI from 12.1 to 1.02 . There was a significant reduction of PASI in the ointment group in comparison with the cream group ( mean PASI from 12.7 to 0.8 and 11.1 to 1.15 , respectively ) . No significant adverse effects were observed in either group , except for mild irritation in a few patients in the calcipotriol cream group . In conclusion , calcipotriol was effective , safe and well tolerated in the treatment of psoriasis vulgaris and better results were observed with the ointment formulation . Longer treatment courses could be advised Background : Corticosteroids are a versatile option for the treatment of mild-to-moderate psoriasis due to their availability in a wide range of potencies and formulations . Occlusion of the corticosteroid is a widely accepted procedure to enhance the penetration of the medication , thereby improving its effectiveness . Betamethasone valerate ( BMV ) is a moderately potent corticosteroid that is available as a cream , ointment , and lotion . A ready-to-use occlusive dressing , which provides a continuous sustained release of BMV , has been developed for the treatment of psoriasis . Objective : To evaluate the efficacy and safety of a new BMV 0.1 % plaster compared with a BMV 0.1 % cream in patients with mild-to-moderate chronic plaque psoriasis . Methods : This was a prospect i ve , r and omized , assessor-blind , parallel-group , active-controlled , multicenter , phase III study . Eligible out patients ( aged ≥18 years ) with a diagnosis of stable , chronic plaque psoriasis vulgaris with two to four plaques on extensor surfaces of limbs were r and omized to receive BMV 0.1 % plaster or BMV 0.1 % cream for 3–5 weeks ; patients with resolution of target plaques then entered a 3-month , treatment-free , follow-up period . The number of patients showing clearing of plaques ( remission ) at 3 weeks ( primary endpoint ) and at 5 weeks was independently evaluated from digitized images of target plaques by two blinded assessors , and also assessed by the investigator and patient . Additional endpoints were ( i ) change from baseline in target plaque size and in Psoriasis Global Assessment ( PGA ) score , as evaluated by the blinded assessors , investigator , and patient ; ( ii ) change from baseline in symptom ( itching , soreness ) severity ; ( iii ) treatment satisfaction and ease of use ; ( iv ) clearing and relapse during the follow-up period ; and ( v ) adverse events ( AEs ) . Results : Patients ( n = 231 ) were screened and r and omized to treatment with BMV 0.1 % plaster ( n = 116 ) and BMV 0.1 % cream ( n = 115 ) . Significantly more patients achieved clearing after 3 weeks ’ treatment with BMV plaster than with BMV cream ( Cochran-Mantel-Haenszel test , p < 0.001 ) ; this difference was maintained at 5 weeks . The total plaque area decreased to a larger extent for the BMV plaster group compared with the BMV cream group ( analysis of covariance [ ANCOVA ] model , p = 0.017 at week 5 ) . PGA scores were significantly lower after 3 and 5 weeks ’ treatment with BMV plaster ( ANCOVA model , all p ≤ 0.016 vs BMV cream ) . Both treatments reduced itching and soreness to a similar degree , and the incidences of relapse during the follow-up period were comparable between treatment groups . There were no significant differences in AEs between treatment groups . Conclusions : BMV 0.1 % plaster is more efficacious than BMV 0.1 % cream in the treatment of patients with mild-to-moderate chronic plaque psoriasis in a clinical setting resembling daily clinical practice . Clinical trial number : IS RCT Two advanced formulations of clobetasol propionate ( CP ) 0.05 % ( Clobex ® Spray ; Galderma Laboratories , L.P. , Fort Worth , TX , USA and Olux ® Foam ; Stiefel/Connetics Corp. , Coral Gables , FL , USA ) were compared in a study of 77 r and omized patients with moderate to severe plaque psoriasis . At the end of the treatment period ( 2 weeks for CP foam or up to 4 weeks for CP spray per product labeling ) , patients treated with CP spray had a median 64 % reduction in affected body surface area ( BSA ) compared to a median 25 % reduction in patients treated with the CP foam ( p = 0.004 ) . Also at the end of the treatment period , 22 % of CP spray‐treated patients were completely clear compared to 5 % of CP foam‐treated patients ( p = 0.04 ) . Improvements in quality of life as determined by the Dermatology Life Quality Index were statistically significantly greater at all time points for patients treated with CP spray compared to patients treated with CP foam ( p<0.04 for all ) . The majority of adverse events for both products were mild in severity . Thus , while both of these formulations contain the same active ingredient at the same concentration , differences in their efficacy were observed when each treatment was used within its approved labeling guidelines Background : Various formulations of clobetasol propionate are currently used to treat psoriasis due to its anti‐inflammatory , anti‐pruritic , vasoconstrictive and immunomodulating properties . Objective : To assess the efficacy , safety and remission profile of clobetasol propionate lotion compared to that of clobetasol propionate emollient cream and lotion vehicle in subjects with moderate to severe plaque‐type psoriasis . Methods : Multicentre , investigator‐blind , r and omized , active‐ and vehicle‐controlled , parallel‐group study . Results : A total of 192 subjects were treated : 82 with clobetasol propionate lotion , 81 with clobetasol propionate cream and 29 with the vehicle . Clobetasol propionate lotion was significantly more effective than vehicle lotion and was comparable in efficacy to the emollient cream after 4 weeks of treatment . Treatment success was higher for subjects in the clobetasol propionate lotion group than in the emollient cream group after 4 weeks of a treatment‐free follow‐up period . Clobetasol propionate lotion was safe and well tolerated . Conclusion : The present study demonstrates that clobetasol propionate lotion is an efficacious , safe and well‐tolerated alternative to the currently available emollient cream formulation , while showing a better remission profile after 4 weeks of treatment‐free follow‐up period
Although the majority of patients with psoriasis vulgaris are treated exclusively with topical therapies , research to develop more effective topical therapies that are associated with higher patient satisfaction has lagged behind the development of systemic agents .
The aim of this literature review was to determine whether there is documented evidence that applying an innovative approach to improving the formulation of active ingredients commonly used in the topical treatment of psoriasis can have a positive effect on clinical outcomes and patient-reported outcomes ( PROs ) .