4.7. Clinical Study
itch, edema, IGA, erythema, itchiness, skin lesion, excoriation
LICHENIFICATION, ADVERSE REACTIONS, EDEMA, MINOR, ERYTHEMA, SKIN LESION, BLIND, SKIN LESIONS
The study was a three-week, randomized, double-blinded, placebo-controlled clinical trial conducted at Yonsei University Severance Hospital (Seoul, Republic of Korea) from October 2018 to February 2019. The protocol was approved by the Yonsei University Severance Hospital Institutional Review Board (IRB protocol no. 4-2018-0124). A total of 23 subjects were screened, and 20 subjects (16 females, 4 males) with Fitzpatrick skin types II-IV enrolled in the study after their written informed consent was approved by the IRB. Inclusion criteria included the following (Subjects were randomly assigned to either a vehicle or an SPM solution. Study subjects were instructed to topically apply either the SPM test solution or the placebo (with vehicle only) exclusively to each randomly designated skin lesion with 1 mL dosage volume per single palm area of skin lesion twice daily (once in the morning and once in the evening). Subjects were also instructed to refrain from local treatments, such as skin peeling and laser treatment, and from using cosmetics containing growth factors or stem cell culture fluids on the application area during this study. The test and vehicle agents were randomly coded, and the subjects and the clinical research staff carrying out the administration, training, and distribution were blind to the contents of the test agents. During self-administration, the subjects returned to the clinic twice: 1 week (±3 days) after treatment initiation for mid-treatment evaluation and 3 weeks (±3 days) after treatment initiation for end-of-treatment evaluation. A dermatology specialist evaluated the skin lesions to which SPM or vehicle had been applied by Investigator Global Assessment (IGA) by scoring the changes in signs or symptoms (erythema, scaling, excoriation, edema, lichenification, and papules) as follows: 1, no improvement; 2, 1–25%; 3, 26–50%; 4, 51–75%; or 5, 76–100% at the end of the study, and via photographic assessment (PA). For PA, two investigators independently evaluated the severity of skin lesion symptoms on a scale of 1 to 5 as they appeared in digital photographs of the skin lesions taken at the beginning and the end of the 3-week treatment. Subject-reported impact on quality of life from the skin symptoms was evaluated from the Dermatological Life Quality Index (DLQI), in which a lower score correlates with a more minor impact at the end of the 3-week application. The degree of itchiness for the SPM or vehicle-applied skin lesion was evaluated using VAS (0–10 scale, lower score correlates to less itch) within the last 24 h from the time of reporting. DLQI and VAS questionnaires were conducted at the beginning and the end of the 3-week treatment. The investigators, board-certified dermatologists, were kept blind to the treatment groups until the end of the study.Outside of subject visits, any adverse reactions during the treatment or within 30 days from the end of treatment were to be reported by the subjects within 24 h of occurrence, and causality between the adverse reactions and the treatment was assessed by the investigator.