A Randomized Controlled Study of a Novel Botanical Acne Spot Treatment
June 2017 | Volume 16 | Issue 6 | Original Article | 599 | Copyright © 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 subject’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.
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Acne is a common dermatologic condition occurring in more than 80% of adolescents age 13 to 18 years with varying severity. Acne prevalence is increasing in young adults older than 25 years, specifically women.1-2 Over the counter (OTC) topical therapy is based on the monographed ingredients benzoyl peroxide (BPO), and salicylic acid (SA). BPO is effective in concentrations ranging from 2.5% to 10% with an antibacterial and comedolytic activity. BPO is poorly tolerated, with the most common side effects being concentration-dependent skin irritation and allergic contact dermatitis. SA functions as a keratolytic agent and is administered topically at concentrations equal and below 2% and functions as an anti-inflammatory. BPO and SA are both effective in reducing lesion counts, however, rapid inflammation and redness reduction is not present in the OTC market.3-6The use of botanicals, as part of alternative or complementary acne treatment, is still not widely available.7-8 In this study we present a new botanical based anti-inflammatory acne treatment that was found to be effective and well tolerated in improving the acne symptoms. An OTC acne treatment (Kamedis Acne Spot Treatment, Kamedis Ltd., Tel-Aviv, Israel), topical gel product consisting of 2% SA and botanicals was studied. The spot treatment is based on herbal botanical ingredients that have been shown to have anti-inflammatory, anti-bacterial, anti-oxidative activity as well as reduction is sebum secretion.9-21 This study was designed to evaluate the tolerability and efficacy of the new presented treatment for acne.
25 subjects, 15 females and 10 males, ages 12 to 43 years, with mild to moderate acne were recruited and qualified for the study. The study was designed as a single-site, investigator-blinded, split-face 10-day study (Dermatology Consulting Services, PLLC, High Point, NC). The study was conducted under Institutional Review Board (Concordia IRB, Beach Haven, NJ), a signed informed consent form and a photographic release form were obtained from each subject prior to performing any study procedure.