Abstract
Background
The efficacy and safety of clindamycin phosphate 1.2%/tretinoin 0.025% (Clin-RA) were evaluated in three 12-week randomised studies.
Objectives
To perform a pooled analysis of data from these studies to evaluate Clin-RA’s efficacy and safety in a larger overall population, in subgroups of adolescents and according to acne severity.
Materials & Methods
4550 patients were randomised to Clin-RA, clindamycin, tretinoin and vehicle. Evaluations included percentage change in lesions, treatment success rate, proportions of patients with ≥50% or ≥80% continuous reduction in lesions, adverse events and cutaneous tolerability.
Results
In the overall population, the percentage reduction in inflammatory, non-inflammatory and total lesions and the treatment success rate were significantly greater with Clin-RA compared with clindamycin, tretinoin and vehicle alone (all p<0.01). The percentage reduction in all types of lesions was also significantly greater with Clin-RA in the adolescent subgroup (2915 patients, p<0.002) and in patients with mild/moderate acne (3662 patients, p<0.02) versus comparators. In patients with severe acne (n = 880), the percentage reduction in all lesion types was significantly greater with Clin-RA versus vehicle (p<0.0001). A greater proportion of Clin-RA treated patients had a ≥50% or ≥80% continuous reduction in all types of lesions at week 12 compared with clindamycin, tretinoin and vehicle. Adverse event frequencies in the active and vehicle groups were similar. Baseline-adjusted mean tolerability scores over time were <1 (mild) and similar in all groups.
Conclusion
Clin-RA is safe, has superior efficacy to its component monotherapies and should be considered as one of the first-line therapies for mild-to-moderate facial acne.
Article PDF
Similar content being viewed by others
References
Thiboutot D, Gollnick H, Bettoli V, et al. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol 2009;60:S1–50.
Gollnick H, Cunliffe W, Berson D, et al. Management of acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol 2003;49:S1–37.
Nast A, Dreno B, Bettoli V, et al. European evidence-based (S3) guidelines for the treatment of acne. J Eur Acad Dermatol Venereol 2012;26(Suppl 1):1–29.
Thielitz A, Helmdach M, Ropke EM, Gollnick H. Lipid analysis of follicular casts from cyanoacrylate strips as a new method for studying therapeutic effects of antiacne agents. Br J Dermatol 2001;145:19–27.
Abdel-Naser MB, Zouboulis CC. Clindamycin phosphate/tretinoin gel formulation in the treatment of acne vulgaris. Expert Opin Pharmacother 2008;9:2931–2937.
Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol 2003;49:S200–S210.
Dreno B. Topical antibacterial therapy for acne vulgaris. Drugs 2004;64:2389–2397.
Jain GK, Ahmed FJ. Adapalene pretreatment increases follicular penetration of clindamycin: in vitro and in vivo studies. Indian J Dermatol Venereol Leprol 2007;73:326–329.
Schlessinger J, Menter A, Gold M, et al. Clinical safety and efficacy studies of a novel formulation combining 1.2% clindamycin phosphate and 0.025% tretinoin for the treatment of acne vulgaris. J Drugs Dermatol 2007;6:607–615.
Del Rosso JQ, Jitpraphai W, Bhambri S, Momin S. Clindamycin phosphate 1.2%-tretinoin 0.025% gel: vehicle characteristics, stability, and tolerability. Cutis 2008;81:405–408.
Del Rosso JQ, Schmidt NF. A review of the anti-inflammatory properties of clindamycin in the treatment of acne vulgaris. Cutis 2010;85:15–24.
Murata K, Tokura Y. Anti-microbial therapies for acne vulgaris: anti-inflammatory actions of anti-microbial drugs and their effectiveness. J UOEH 2007;29:63–71.
Cunliffe WJ, Poncet M, Loesche C, Verschoore M. A comparison of the efficacy and tolerability of adapalene 0.1% gel versus tretinoin 0.025% gel in patients with acne vulgaris: a meta-analysis of five randomized trials. Br J Dermatol 1998;139(Suppl 52):48–56.
Goreshi R, Samrao A, Ehst BD. A double-blind, randomized, bilateral comparison of skin irritancy following application of the combination acne products clindamycin/tretinoin and benzoyl peroxide/adapalene. J Drugs Dermatol 2012;11:1422–1426.
Tanghetti EA. The role of inflammation in the pathology of acne. J Clin Aesthet Dermatol 2013;6:27–35.
Kircik LH, Peredo MI, Bucko AD, et al. Safety of a novel gel formulation of clindamycin phosphate 1.2%-tretinoin 0.025%: results from a 52-week open-label study. Cutis 2008;82:358–366.
Jackson JM, Fu JJ, Almekinder JL. A randomized, investigatorblinded trial to assess the antimicrobial efficacy of a benzoyl peroxide 5%/clindamycin phosphate 1% gel compared with a clindamycin phosphate 1.2%/tretinoin 0.025% gel in the topical treatment of acne vulgaris. J Drugs Dermatol 2010;9:131–136.
Cunliffe WJ, Holland KT, Bojar R, Levy SF. A randomized, doubleblind comparison of a clindamycin phosphate/benzoyl peroxide gel formulation and a matching clindamycin gel with respect to microbiologic activity and clinical efficacy in the topical treatment of acne vulgaris. Clin Ther 2002;24:1117–1133.
Fu LW, Vender RB. Newer approaches in topical combination therapy for acne. Skin Therapy Lett 2011;16:3–6.
Yentzer BA, Ade RA, Fountain JM, et al. Simplifying regimens promotes greater adherence and outcomes with topical acne medications: a randomized controlled trial. Cutis 2010;86:103–108.
Dreno B, Thiboutot D, Gollnick H, et al. Large-scale worldwide observational study of adherence with acne therapy. Int J Dermatol 2010;49:448–456.
Zaghloul SS, Cunliffe WJ, Goodfield MJ. Objective assessment of compliance with treatments in acne. Br J Dermatol 2005;152:1015–1021.
Kellett N, West F, Finlay AY. Conjoint analysis: a novel, rigorous tool for determining patient preferences for topical antibiotic treatment for acne. A randomised controlled trial. Br J Dermatol 2006;154:524–532.
Leyden JJ, Hickman JG, Jarratt MT, Stewart DM, Levy SF. The efficacy and safety of a combination benzoyl peroxide/clindamycin topical gel compared with benzoyl peroxide alone and a benzoyl peroxide/erythromycin combination product. J Cutan Med Surg 2001;5:37–42.
Ellis CN, Leyden J, Katz HI, et al. Therapeutic studies with a new combination benzoyl peroxide/clindamycin topical gel in acne vulgaris. Cutis 2001;67:13–20.
Author information
Authors and Affiliations
Corresponding author
About this article
Cite this article
Dréno, B., Bettoli, V., Ochsendorf, F. et al. Efficacy and safety of clindamycin phosphate 1.2%/tretinoin 0.025% formulation for the treatment of acne vulgaris: pooled analysis of data from three randomised, double-blind, parallel-group, phase III studies. Eur J Dermatol 24, 201–209 (2014). https://doi.org/10.1684/ejd.2014.2293
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1684/ejd.2014.2293