Adapalene–benzoyl peroxide, a unique fixed‐dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double‐blind, controlled study in 1670 patients
Summary Background Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed‐dose combination gel with adapalene 0·1% and benzoyl peroxide (BPO) 2·5% has recently...
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| Published in | British journal of dermatology (1951) Vol. 161; no. 5; pp. 1180 - 1189 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.11.2009
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0007-0963 1365-2133 1365-2133 |
| DOI | 10.1111/j.1365-2133.2009.09209.x |
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| Abstract | Summary
Background Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed‐dose combination gel with adapalene 0·1% and benzoyl peroxide (BPO) 2·5% has recently been developed for the once‐daily treatment of acne.
Objectives To evaluate the efficacy and safety of adapalene 0·1%–BPO 2·5% fixed‐dose combination gel (adapalene–BPO) relative to adapalene 0·1% monotherapy (adapalene), BPO 2·5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris.
Methods In total, 1670 subjects were randomized in a double‐blind controlled trial to receive adapalene–BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects ‘clear’ or ‘almost clear’), percentage change in lesion count from baseline, cutaneous tolerability and adverse events.
Results Adapalene–BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild‐to‐moderate dry skin), occurred early in the study, and were transient.
Conclusions Adapalene–BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies. |
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| AbstractList | SummaryBackground Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has recently been developed for the once-daily treatment of acne.Objectives To evaluate the efficacy and safety of adapalene 0.1%-BPO 2.5% fixed-dose combination gel (adapalene-BPO) relative to adapalene 0.1% monotherapy (adapalene), BPO 2.5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris.Methods In total, 1670 subjects were randomized in a double-blind controlled trial to receive adapalene-BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects 'clear' or 'almost clear'), percentage change in lesion count from baseline, cutaneous tolerability and adverse events.Results Adapalene-BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild-to-moderate dry skin), occurred early in the study, and were transient.Conclusions Adapalene-BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies. Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has recently been developed for the once-daily treatment of acne. To evaluate the efficacy and safety of adapalene 0.1%-BPO 2.5% fixed-dose combination gel (adapalene-BPO) relative to adapalene 0.1% monotherapy (adapalene), BPO 2.5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris. In total, 1670 subjects were randomized in a double-blind controlled trial to receive adapalene-BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects 'clear' or 'almost clear'), percentage change in lesion count from baseline, cutaneous tolerability and adverse events. Adapalene-BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild-to-moderate dry skin), occurred early in the study, and were transient. Adapalene-BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies. Summary Background Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed‐dose combination gel with adapalene 0·1% and benzoyl peroxide (BPO) 2·5% has recently been developed for the once‐daily treatment of acne. Objectives To evaluate the efficacy and safety of adapalene 0·1%–BPO 2·5% fixed‐dose combination gel (adapalene–BPO) relative to adapalene 0·1% monotherapy (adapalene), BPO 2·5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris. Methods In total, 1670 subjects were randomized in a double‐blind controlled trial to receive adapalene–BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects ‘clear’ or ‘almost clear’), percentage change in lesion count from baseline, cutaneous tolerability and adverse events. Results Adapalene–BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild‐to‐moderate dry skin), occurred early in the study, and were transient. Conclusions Adapalene–BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies. Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has recently been developed for the once-daily treatment of acne.BACKGROUNDCombination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has recently been developed for the once-daily treatment of acne.To evaluate the efficacy and safety of adapalene 0.1%-BPO 2.5% fixed-dose combination gel (adapalene-BPO) relative to adapalene 0.1% monotherapy (adapalene), BPO 2.5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris.OBJECTIVESTo evaluate the efficacy and safety of adapalene 0.1%-BPO 2.5% fixed-dose combination gel (adapalene-BPO) relative to adapalene 0.1% monotherapy (adapalene), BPO 2.5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris.In total, 1670 subjects were randomized in a double-blind controlled trial to receive adapalene-BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects 'clear' or 'almost clear'), percentage change in lesion count from baseline, cutaneous tolerability and adverse events.METHODSIn total, 1670 subjects were randomized in a double-blind controlled trial to receive adapalene-BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects 'clear' or 'almost clear'), percentage change in lesion count from baseline, cutaneous tolerability and adverse events.Adapalene-BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild-to-moderate dry skin), occurred early in the study, and were transient.RESULTSAdapalene-BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild-to-moderate dry skin), occurred early in the study, and were transient.Adapalene-BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies.CONCLUSIONSAdapalene-BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies. |
| Author | Cornelison, R. Rosoph, L.A. Kaszuba, A. Gore, B. Graeber, M. Draelos, Z. Glenn, M.J. Liu, Y. Gollnick, H.P.M. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/19466959$$D View this record in MEDLINE/PubMed |
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| Contributor | Toole, John Jack Sofen, Howard Moore, Angela Nigen, Simon Carey, Wayne Hamilton, Tiffani Stein, Kenneth Thomas, Richard Lynde, Charles Sebastian, Michael Simola, Margit Cook-Bolden, Fran Schroeder, Meike Albrecht, Lorne Kloeverkorn, Winfried Dinehart, Scott Michael Moore, Jeffery Rafal, Elyse Toth, Darryl Weintraub, James Hamlin, Regina Gerlach, Beatrice Haydey, Richard Silney, Wojciech Dinulos, James Hamzavi, Iltefat Birchmore-Musick, Melinda Knoepp, Theresa Maari, Catherine Weintraub, Gerald Wilkerson, Michael Bihari, Agnes Dawes, Kenneth Barber, Kirk Taub, Amy Forman Zane, Lee Rist, Toivo Checketts, Scott Dirschka, Thomas Placek, Waldemar Pres, Henrik Kunynetz, Rod Landells, Ian Ehrlich, Alison Del Rosso, James Pandya, Amit Baker, Diane Cornelison, Raymond Hollo, Peter Popp, Georg Murakawa, George Griff, Charles Krusinski, Paul Tucker, Lynn Scott, Richard Wasel, Norman Cox, David |
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| Copyright | 2009 The Authors. Journal Compilation © 2009 British Association of Dermatologists |
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| Notes | Reprint requests should be directed to Michael Graeber.
E‐mail Conflicts of interest This study was funded by Galderma R&D, Princeton, NJ, U.S.A. The investigating authors received payments for this research project. B.G., Y.L. and M.G. are employees of Galderma R&D. H.P.M.G. has served as a speaker for Galderma Laboratories. ClinicalTrials.gov registration number: NCT00421993 michael.graeber@galderma.com ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Article-1 ObjectType-Feature-2 ObjectType-Undefined-3 |
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| References | 1980; 302 2004; 64 2000 1997; 53 2004; 14 1997; 37 1997; 36 2004; 15 1982; 21 2004; 292 2005; 4 2007; 6 2003; 49 2005; 6 2001; 15 1998; 139 2003; 42 2007; 57 2007; 16 |
| References_xml | – volume: 49 start-page: S200 issue: Suppl. year: 2003 end-page: 10 article-title: A review of the use of combination therapies for the treatment of acne vulgaris publication-title: J Am Acad Dermatol – volume: 42 start-page: 1287 year: 2003 end-page: 304 article-title: Transdermal penetration of topical drugs used in the treatment of acne publication-title: Clin Pharmacokinet – volume: 139 start-page: 8 issue: Suppl. 52 year: 1998 end-page: 11 article-title: Chemical stability of adapalene and tretinoin when combined with benzoyl peroxide in presence and in absence of visible light and ultraviolet radiation publication-title: Br J Dermatol – volume: 292 start-page: 726 year: 2004 end-page: 35 article-title: Treatment of acne vulgaris publication-title: JAMA – volume: 64 start-page: 1465 year: 2004 end-page: 78 article-title: Adapalene: a review of its use in the treatment of acne vulgaris publication-title: Drugs – volume: 53 start-page: 511 year: 1997 end-page: 19 article-title: Adapalene: a review of its pharmacological properties and clinical potential in the management of mild to moderate acne publication-title: Drugs – volume: 16 start-page: 500 year: 2007 end-page: 6 article-title: modulation of TLR‐2, CD1d and IL‐10 by adapalene on normal human skin and acne inflammatory lesions publication-title: Exp Dermatol – year: 2000 – volume: 15 start-page: 372 year: 2004 end-page: 8 article-title: A successful maintenance approach in inflammatory acne with adapalene gel 0·1% after an initial treatment in combination with clindamycin topical solution 1% or after monotherapy with clindamycin topical solution 1% publication-title: J Dermatolog Treat – volume: 4 start-page: 611 year: 2005 end-page: 18 article-title: Comparison of clindamycin/benzoyl peroxide, tretinoin plus clindamycin, and the combination of clindamycin/benzoyl peroxide and tretinoin plus clindamycin in the treatment of acne vulgaris: a randomized, blinded study publication-title: J Drugs Dermatol – volume: 302 start-page: 503 year: 1980 end-page: 6 article-title: Current concepts: topical therapy for acne publication-title: N Engl J Med – volume: 4 start-page: 138 year: 2005 end-page: 46 article-title: Combination therapy with adapalene gel 0·1% and doxycycline for severe acne vulgaris: a multicenter, investigator‐blind, randomized, controlled study publication-title: SkinMED – volume: 21 start-page: 770 year: 1982 end-page: 2 article-title: Suppression of polymorphonuclear leukocyte chemotactic factor production in by subminimal inhibitory concentrations of tetracyclines and erythromycin publication-title: Antimicrob Agents Chemother – volume: 49 start-page: S218 issue: Suppl. year: 2003 end-page: 26 article-title: Is combined oral and topical therapy better than oral therapy alone in patients with moderate to moderately severe acne vulgaris? 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Background Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously... Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple... SummaryBackground Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target... |
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| SubjectTerms | acne Acne Vulgaris - drug therapy Adapalene Administration, Cutaneous Adolescent Adult Anti-Infective Agents, Local - adverse effects Anti-Infective Agents, Local - therapeutic use benzoyl peroxide Benzoyl Peroxide - adverse effects Benzoyl Peroxide - therapeutic use Child combination therapy Dermatologic Agents - adverse effects Dermatologic Agents - therapeutic use Double-Blind Method Drug Combinations Female Gels - therapeutic use Humans Male Middle Aged Naphthalenes - adverse effects Naphthalenes - therapeutic use randomized controlled trial Treatment Outcome Young Adult |
| Title | Adapalene–benzoyl peroxide, a unique fixed‐dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double‐blind, controlled study in 1670 patients |
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