Assessing the Value of Botanical Anti-Inflammatory Agents in an OTC Acne Treatment Regimen
December 2015 | Volume 14 | Issue 12 | Original Article | 1418 | Copyright © December 2015
Zoe Diana Draelos MD
Dermatology Consulting Services, High Point, NC
BACKGROUND: Over-the-counter acne treatments have assumed more importance for the dermatologist as access and affordability of prescription acne medications has decreased.
AIM: This research evaluated the efficacy of a three step acne treatment regimen containing stabilized botanical anti-inflammatory ingredients as compared to a currently marketed acne regimen.
METHOD: 80 female/male subjects 12+ years with mild to moderate acne (at least 10 inflammatory and 10 non-inflammatory lesions) were enrolled for 12 weeks and randomized to use the study botanical anti-inflammatory acne regimen or the traditional benzoyl peroxide
comparator. Evaluations included investigator global assessment, investigator tolerability assessment, acne lesion characteristics (erythema, lesion height, diameter of inflammation, and amount of pus), subject product assessment, and digital photos at baseline, 2, 4, and 12 weeks.
RESULTS: The botanical regimen outperformed the comparator in terms of target lesion erythema, height, inflammation, and pus at weeks 2 and 4, perhaps due to anti-inflammatory ingredients, however parity was reached between the two products by week 12. No difference in lesion counts between the two groups was noted at week 2, however by week 4, there was a lower lesion count with the study regimen in terms of closed comedones (P
<0.001) and inflammatory (P
=0.016) lesions than the comparator. This statistically significant difference continued into week 12 with a reduction in closed comedones (P
=0.006) for the study regimen.
CONCLUSION: Modern OTC cosmetic formulation ingredients including emollients, anti-inflammatory/antioxidants, and sensitive skin modulators provided an improved skin appearance, less lesional erythema, and a better overall appearance in subjects with acne treated for 12 weeks. J Drugs Dermatol.
There has been tremendous growth in the over-the-counter
(OTC) drug acne market since the FDA decision to move 10% and lower benzoyl peroxide cleansers and creams out of the pharmaceutical realm.1 Further, new insurance
plans requiring higher insurance deductibles for both office
visits and medications have restricted access to dermatologists
and prescription medications. OTC medications that make acne treatment claims must use ingredients on the acne monograph
at or below the stated concentration. This means many acne formulations are based on salicylic acid (SA) and benzoyl peroxide (BPO) as the acne agent leaving little room for formulation
creativity or product distinction.2
While both SA and BPO are effective, there are still unmet needs in the OTC acne treatment arena. Specifically, rapid inflammation reduction to minimize acne lesion pigmentation
remains a challenge. This research evaluated the efficacy of an acne treatment regimen (skin cleanser, breakout treatment,
tone, and complexion corrector) rich in botanical stabilized anti-inflammatories versus a popular currently marketed acne treatment regimen.
80 female/male subjects 12+ years of age in good general health with mild to moderate acne defined as a minimum of 10 inflammatory lesions (papules, pustules), a minimum of 10 non-inflammatory lesions (open comedones, closed comedones),
and 2 or less cystic lesions were enrolled a single center (Dermatology Consulting Services, High Point, NC) prospective 12-week double blind IRB approved study (Concordia IRB, Cedar
Knolls, NJ). All female subjects demonstrated a negative urine pregnancy test. 40 subjects were randomized to use the study regimen (RU)(Clear Skin Cleanser, Breakout Treatment, Clear Tone & Complexion Corrector; Receutics, Rite Aid) and another 40 subjects were randomized to use the currently marketed
acne kit (PR)(ProActive; Gunthy Reiker). The assigned acne treatment regimen was used twice daily with recorded in a diary for compliance. Subjects were not allowed to use any other acne treatment products, except for those provided.
Subjects were evaluated at baseline, week 2, week 4, and week 12. Assessments included investigator skin appearance evaluations,
acne lesions counts, investigator global assessment, investigator tolerability assessment, acne lesion characteristics