Patients and methods
atopic dermatitis, trichotillomania, fullness, hypotrichosis, dermatitis
SYSTEMIC DISEASE, EYEBROW LOSS, ALOPECIA AREATA, THYROID DISEASES, HYPOTRICHOSIS
This was a randomized, triple armed single blinded randomized study to compare the efficacy and safety of topical 0.01% and 0.03% bimatoprost versus topical 2% minoxidil. The sample size was calculated based on data from a previous comparative study in a Thai population, with a 5% significance level and 90% power. The calculated minimum number of subjects was 50. Considering dropout, we recruited a total of 60 subjects. This study was approved by the ethical committee for research in AL-Azhar University, Damietta faculty of medicine and all patients provided written informed consent prior to starting the study.
Sixty eligible subjects were female or male, aged 18 years or older with eyebrow hypotrichosis, defined as either a Grade 1 or 2 on the Global Eyebrow Assessment (GEBA) scale. The GEBA instrument is a validated 4-point scale used to grade fullness of the eyebrows (1 = very sparse, 2 = sparse, 3 = full, and 4 = very full). Subjects with recent eye operations, those suffering from systemic diseases that can possibly affect eyebrow loss; alopecia areata, trichotillomania, thyroid diseases, atopic dermatitis, seborrheic dermatitis; and those receiving treatment of hypotrichosis within 6 months of enrollment were excluded. Females who had microblading, eyebrow tattoos at screening and female subjects who were pregnant, nursing, or planning for a pregnancy during the study were excluded.Patients were randomized into 3 groups using block randomization. Group a (20 patients) applied topical 0.03% bimatoprost gel once daily onto both eyebrows, group b (20 patients) applied topical 0.01% bimatoprost gel once daily onto both eyebrows while group c (20 patients) applied topical minoxidil 2% gel once daily onto both eyebrows. Containers were identical and were different in color for each. Each bottle was labeled with a container number, dosing instruction, and storage condition. Containers were provided to subjects and refilled at every scheduled follow up monthly visit.The study was scheduled for 16 weeks and at every visit standard photographs were taken using digital camera and trichoscopic eyebrow assessment was carried out using DL-4.Hair count and diameter were assessed using a folliscope and measurements were performed up a vertical line drawn from mid papillary line. Eyebrow number and diameter were analyzed using image analysis software and by manual count.For outcomes, the GEBA scale was evaluated from standard photographs by two blinded dermatologists as subjective parameter in every visit. Another outcome measurement in our study was the 7-point rating scale, defined as follows: marked deterioration (− 3), moderate deterioration (− 2), slight deterioration (− 1), no change (0), slight improvement (+ 1), moderate improvement (+ 2), and marked improvement (+ 3).