Efficacy of Topical 4% Quassia amara Gel in Facial Seborrheic Dermatitis:A Randomized, Double-Blind, Comparative Study
March 2013 | Volume 12 | Issue 3 | Original Article | 312 | Copyright © March 2013
Christian Diehl MDa and Alicia Ferrari MDb
aUniversidad Nacional de Córdoba, Córdoba, Argentina bUniversidad FASTA, Mar del Plata, Argentina
BACKGROUND: Seborrheic dermatitis (SD) is a chronic mild skin disorder with high prevalence. Various treatment options are available, including topical antifungals and anti-inflammatories. Antifungal and anti-inflammatory properties of Quassia amara have been reported.
AIM: To check the efficacy and safety of a topical gel with 4% Quassia amara extract and compare it with topical 2% ketoconazole and 1% topical ciclopiroxolamine in the treatment of facial SD.
METHODS: A group of 60 patients displaying facial SD were randomly distributed in 3 groups and given either a topical gel with 4% Quassia amara extract, a topical gel with 2% ketoconazole, or a topical gel with 1% ciclopirox olamine for 4 weeks.
Disease severity was assessed at the start and weekly along treatment, as well as 4 weeks after the end of treatment. In each selected area, severity of erythema, scaling, pruritus, and papules were scored from 0 to 3, the sum of these values representing the score of SD on the face. This evaluation was conducted at each visit. The decrease in SD score with all 3 products was compared at each visit. At each stage, overall improvement, safety, and tolerability were also assessed.
RESULTS: Of the 60 patients, 54 (90%) completed the study. The 3 therapeutic options resulted to be very effective, with a significant advantage in efficacy for 4% Quassia extract. For the other 2 drugs, the results were in line with those previously published in the literature.
CONCLUSION: Topical gel with 4% Quassia extract represents a new, safe, and effective treatment for facial SD. J Drugs Dermatol.
Seborrheic dermatitis (SD) is a chronic, relapsing mild skin disorder presenting as sharply defined erythematous patches and plaques with greasy scales, with a predilection in areas with increased density of sebaceous glands, namely the scalp, face, upper trunk, and flexures.1,2 It affects approximately 3% to 5% of the population,3,4 with an even higher density among patients with AIDS, Parkinson’s disease, or several other medical conditions.3
The prevalence is higher among subjects older than 40 years.4 Infantile seborrheic dermatitis has a higher prevalence (up to 70% of newborns during the first 3 months of life),5 but there is still debate as to whether it represents a distinct dermatitis.1
The pathogenesis of the disease is still not fully understood. The yeast Malassezia species has long been pointed out, but its role remains unclear. However, the number of yeasts logically decreases with antifungal treatment, resulting in clinical improvement and increases in periods of exacerbation.6 Malassezia metabolism was shown to alter sebum composition and promotes inflammation in susceptible individuals.7 Induction of inflammatory cytokine production by keratinocytes was also suggested.8
The standard course of treatment remains the topical antifungals, especially 2% ketoconazole (KCZ) and 1% ciclopirox olamine (CIC). In case of severe SD, low- or medium-potency
topical corticosteroids such as 1% hydrocortisone or 0.05% betamethasone dipropionate are also helpful.
Quassia amara features a shrub or small tree originating in South America and containing high levels of active phytochemicals, including the triterpenoid quassinoids. Various biological activities are described in the literature, including antimicrobial and antifungal activities,9 especially on Malassezia yeast (L. Fraenza MD, unpublished data, 2010) and strong anti-inflammatory properties.10,11
Because of the previously disclosed properties, we have successfully administered a topical hydroglycolic extract of Quassia (QX) to patients with SD, and their satisfaction and these unexpected results prompted our decision to conduct a randomized, double-blind comparative study with this topical preparation vs 2% KCZ and 1% CIC.
MATERIALS AND METHODS
Study Design This is a randomized, double-blind study comparing the efficacy of a test gel containing 4% QX vs 2% KCZ gel and 1% CIC gel.
The study comprised 60 patients who were randomly assigned to receive either a topical 4% QX gel (n=20), a 2% KCZ gel (n=20), or a 1% CIC gel (n=20). The determination of sample size was established with Lenth’s calculator