Tolerability and Irritation Potential of Four Topical Acne Regimens in Healthy Subjects
June 2013 | Volume 12 | Issue 6 | Original Article | 644 | Copyright © June 2013
Gary Grove PhD,a Charles Zerweck PhD,a and Jennifer Gwazdauskas MBAb
acyberDERM Clinical Studies, Lawrence Park Industrial Park, Broomall, PA bStiefel, a GSK company, Research Triangle Park, NC
Abstract
Benzoyl peroxide (BPO) is a cornerstone of acne therapy, often used in combination with a topical antibiotic and/or a retinoid. Three
independent 2-week studies were conducted in healthy subjects to compare the tolerability and irritation potential of topical treatment
with Duac® Gel (BPO 5%–clindamycin phosphate 1.2%) vs Acanya® Gel (BPO 2.5%–clindamycin phosphate 1.2%), Aczone® Gel (dapsone
5%), or Epiduo® Gel (BPO 2.5%–adapalene 0.1%). For each study, subjects were randomized to apply one of the comparative
products on one side of the face; the contralateral side remained untreated. Primary (erythema and dryness) and secondary tolerability
assessments were performed throughout the study. Independent blinded expert grader assessments of erythema found no significant
overall difference between any of the comparative groups. Treatment with Epiduo Gel resulted in a significant increase in dryness
and evaporative water loss values compared with Duac Gel. Overall, subject self-assessments were equally favorable across all study
groups, although the Epiduo Gel group reported a higher frequency of adverse perceptions (ie mild burning/stinging). In conclusion,
the four topical acne medications tested were well tolerated throughout the study period. Treatment with Epiduo Gel resulted in a
significant increase in dryness, evaporative water loss, and sensations of burning and stinging. No other significant differences in self-assessment
perceptions were observed between treatments.
J Drugs Dermatol. 2013;12(6):644-649.
INTRODUCTION
Benzoyl peroxide (BPO) is a cornerstone of acne therapy
that is often used in combination with a topical antibiotic
and/or a retinoid. The use of varying concentrations of BPO
with an antibiotic such as clindamycin (as clindamycin phosphate
1.2%) minimizes the emergence of antibacterial resistance1 while
enhancing efficacy compared with the individual agents.2,3 Furthermore,
topical fixed-dose combinations of BPO and clindamycin
phosphate 1.2% possess very low irritation potential4,5 and are
often better tolerated than either agent alone.3 Improved tolerability
of a fixed-combination of BPO–clindamycin phosphate 1.2%
has also been demonstrated in combination with a retinoid.6
The tolerability and efficacy of topical fixed-dose combinations
of low-strength BPO (2.5%) with either clindamycin phosphate
1.2% (Acanya® Gel)7–9 or adapalene 0.1% (Epiduo® Gel) have
been widely demonstrated.10–14 The antibacterial dapsone 5%
gel (Aczone® Gel) used alone15,16 or in combination with BPO
(4%)17 is also an effective and well tolerated acne treatment.18
Acanya Gel results in less irritation than a higher concentration
of BPO (5%) in combination with clindamycin phosphate 1.2%
(Duac® Gel).19 No studies have compared the safety and tolerability
of Duac Gel with Epiduo Gel or Aczone Gel.
The primary objectives of the three studies described here were
to evaluate the tolerability and irritation potential of Duac Gel
compared with Acanya Gel, Aczone Gel, or Epiduo Gel. Secondary
objectives included assessment of potential changes in the
integrity of the stratum corneum barrier and skin surface hydration
after each treatment, and estimation of subject tolerability
through skin assessment questionnaire and Product Acceptability
and Preference Questionnaire.
METHODS
Eligible Subjects
Three independent single-blind, single-center, parallel group,
randomized, 2-week studies were conducted between May
and September 2009 in healthy subjects to evaluate the
tolerability and irritation potential of topical Duac Gel (BPO 5%–
clindamycin phosphate 1.2%) compared with Acanya Gel (BPO
2.5%–clindamycin phosphate 1.2%), Aczone Gel (dapsone 5%),
or Epiduo Gel (BPO 2.5%–adapalene 0.1%).
Eligible volunteers (screened 3 days prior to randomization)
were males and females aged 18 to 45 years who did not have
facial acne, and had a Fitzpatrick Skin Type of I, II, or III. All
study procedures and protocols were reviewed and approved
by the institutional review board in accordance with the International
Conference on Harmonization Good Clinical Practice
Guidelines, Good Laboratory Practice Guidelines, and COLIPA
(European Cosmetics Trade Association) Efficacy Testing
Guidelines (Study numbers NCT01015638, NCT00964366, and
NCT00926367; www.clinicaltrials.gov).