ABSTRACT
BACKGROUND: Selenium sulfide, available as a shampoo or topical lotion at 1%, or 2.5% concentrations in India, is used as a topical antiseborrheic and antifungal for the treatment of dandruff, seborrheic dermatitis, psoriasis, and tinea versicolor. In the present study, the safety, efficacy, and attributes of 2.5% selenium sulfide shampoo were evaluated in Indian participants with dandruff. METHODS: A single-center, single-arm, prospective, investigator-initiated, open-label, post-marketing interventional study was conducted on Indian subjects aged 18-70 years diagnosed with moderate dandruff who were prescribed 2.5% selenium sulfide shampoo every three days for four weeks. The primary endpoints were 1) reduction in total dandruff score assessed using a clinical grading scale for adherent and loose dandruff from baseline to weeks 1, 2, and 4, and 2) incidence of adverse events up to the end of the study. The key secondary endpoints were 1) participants' perception of shampoo attributes (dandruff reduction, scalp itch, scalp oiliness/greasiness, or fragrance) as assessed by a subjective self-assessment questionnaire post-first wash and at weeks 1, 2, and/or 4; 2) satisfaction with treatment as assessed by investigators and participants using a subjective self-assessment questionnaire at week 4; and 3) reduction in scalp sebum as assessed with a meibometer at weeks 2 and 4. Statistical analysis was performed using the Wilcoxon signed-rank test for continuous variables and the Chi-square test for categorical variables. A p-value of 0.05 was considered to be statistically significant. RESULTS: Of 34 enrolled subjects, 30 completed the four-week study. The mean (standard deviation, SD) age of the study participants was 29.8 (7.87) years, with the majority being females (n=18; 60.0%). Mean (SD) total dandruff score significantly (p=0.001) reduced from a baseline score of 11.5 (2.15) to 7.17 (2.12) at week 1, 4.93 (1.72) at week 2, and 2.5 (1.17) at week 4. All the participants reported dandruff reduction and acceptable fragrance of the shampoo at four weeks. Absence of itching and reduction in oiliness was reported by 73.3% (n=22) of participants at week 4 and by 50.0% (n=15) of participants at week 2, respectively. All participants reported good, very good, or excellent satisfaction with the test shampoo at week 4, whereas the investigators rated the shampoo as very good or excellent in managing dandruff in all participants. At week 4, erythema was reported to be absent in all participants. No adverse events were reported during the study. CONCLUSIONS: The 2.5% selenium sulfide shampoo was found to be effective in the management of dandruff and related symptoms like itching, oiliness, and greasiness and had a good safety profile in Indian participants with dandruff.
