A Randomized Controlled Study of a Novel Botanical Acne Spot Treatment
June 2017 | Volume 16 | Issue 6 | Original Article | 599 | Copyright © June 2017
Deganit Barak-Shinar PhDa and Zoe Diana Draelos MDb
aKamedis Ltd. Tel-Aviv, Israel bDermatology Consulting Services, PLLC, High Point, NC
OBJECTIVE: The study evaluated the tolerability and efficacy of a new presented treatment for acne. The product is an OTC topical gel consisting of 2% SA, which is also enriched in botanicals that have been shown to have anti-inflammatory properties.
DESIGN: The study was designed as a single-site, randomized, investigator-blinded, split-face 10-day study.
SETTING: Subjects enrolled with a minimum of 2 inflammatory papular acne lesions and 2 non-inflammatory open or closed comedones on both sides of the face in symmetrical locations, to the greatest degree possible. One side of each subjectâ€™s face was randomly selected to receive the study treatment product.
PARTICIPANTS: 25 subjects, 15 female and 10 males, ages 12 to 43 years, suffering from mild to moderate acne.
Measurements: Study duration was 10 days, with study visits occurring at baseline (day 0), day 1, day 2, day 3, day 7, and day 10. Subjects underwent investigator facial evaluation and lesion assessment by dermatologist at each of the visit days. For the inflammatory lesions, the assessed parameters were erythema, elevation, induration, and overall impression. The assessed non-inflammatory parameters were elevation and overall impression.
Results: The observed difference between the treatment and the control group increased between day 1 and day 2 and reached an average of 15% to 20% with small varieties between the parameters and stayed similar across the remaining visits. Statistically significance (P less than 0.005) was achieved for all inflammatory and non-inflammatory tested parameters.
Conclusion: This study was performed to determine the safety, efficacy, and ease of use of a botanical acne treatment gel in providing a reduction in inflammatory acne lesion erythema, elevation, and induration. Erythema and elevation were the most influential parameters in inflammatory lesion with improvement noted after 2 days of application.
J Drugs Dermatol. 2017;16(6):599-603.