Adapalene-benzoyl peroxide once-daily, fixed-dose combination gel for the treatment of acne vulgaris: A randomized, bilateral (split-face), dose-assessment study of cutaneous tolerability in healthy participants

Cutis

Volumn 81, Issue 3, 2008, Pages 278-284

  Andres, Philippe ^a,b   Pernin, Colette ^a,b   Poncet, Michel ^a,b  

^a Galderma R and D   (France)

^b Galderma

Author keywords

[No Author keywords available]

Indexed keywords

ADAPALENE; BENZOYL PEROXIDE; DERMATOLOGICAL AGENT; NAPHTHALENE DERIVATIVE;

ACNE VULGARIS; ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG COMBINATION; FACE; FEMALE; HUMAN; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ACNE VULGARIS; ADULT; AGED; BENZOYL PEROXIDE; DERMATOLOGIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; FACE; FEMALE; HUMANS; MALE; MIDDLE AGED; NAPHTHALENES; TREATMENT OUTCOME;

EID: 42149096007     PISSN: 00114162     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (26)

1. Thiboutot D. Regulation of human sebaceous glands. J Invest Dermatol. 2004;123:1-12.
2. Pawin H, Beylot C, Chivot M, et al. Physiopathology of acne vulgaris: recent data, new understanding of the treatments. Eur J Dermatol. 2004;14:4-12.
3. Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003;49(suppl 3):S200-S210.
4. 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 (suppl 1):S1-S37.
5. Thiboutot D. New treatments and therapeutic strategies for acne. Arch Family Med. 2000;9:179-187.
6. Gollnick H, Schramm M. Topical drug treatment in acne. Dermatology. 1998;196:119-125.
7. Brogden RN, Goa KL. Adapalene: a review of its pharmacological properties and clinical potential in the management of mild to moderate acne. Drugs. 1997;53: 511-519.
8. Michel S, Jomard A, Demarchez M. Pharmacology of adapalene. Br J Dermatol. 1998;139(suppl 52):3-7.
9. Vega B, Jomard A, Michel S. Regulation of human monocyte toll-like receptor 2 (TLR2) expression by adapalene [abstract]. J Eur Acad Dermatol Venereol. 2002;16 (suppl 1):123-124.
10. Shroot B, Michel S. Pharmacology and chemistry of adapalene. J Am Acad Dermatol. 1997;36(6, pt 2):S96-S103.
11. Haider A, Shaw JC. Treatment of acne vulgaris. JAMA. 2004;292:726-735.
12. Cunliffe WJ, Poncet M, Loesche C, et al. 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;139:48-56.
13. Waugh J, Noble S, Scott LJ. Adapalene: a review of its use in the treatment of acne vulgaris. Drugs. 2004;64:1465-1478.
14. Plewig G, Kligman AM. Acne and Rosacea. 3rd ed. New York, NY: Springer-Verlag; 2000.
15. Webster GF, Leyden JJ, McGinley KJ, et al. Suppression of polymorphonuclear leukocyte chemotactic factor production in Propionibacterium acnes by subminimal inhibitory concentrations of tetracyclines and erythromycin. Antimicrob Agents Chemother. 1982;21:770-772.
16. Bowman S, Gold M, Nasir A, et al. 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. J Drugs Dermatol 2005;4:611-618.
17. Mills OH Jr, Kligman AM, Pochi P, et al. Comparing 2.5%, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris, Int J Dermatol. 1986;25:664-667.
18. Data on file. Four-week repeat dose dermal toxicity and toxicokinetic study in beagle dogs. Sophia Antipolis, France: Galderma R&D; 2003.
19. Martin B, Meunier C, Montels D, et al. Chemical stability of adapalene and tretinoin when combined with benzoyl peroxide in presence and in absence of visible light and ultraviolet radiation. Br J Dermatol. 1998;139(suppl 52): 8-11.
20. Brand B, Gilbert R, Baker MD, et al. Cumulative irritancy comparison of adapalene gel 0.1% versus other retinoid products when applied in combination with topical antimicrobial agents. J Am Acad Dermatol. 2003;49(suppl 3): S227-S232.
21. Caron D, Sorba V, Clucas A, et al. Skin tolerance of adapalene 0.1% gel in combination with other topical antiacne treatments. J Am Acad Dermatol. 1997;36(6, pt 2): S113-S115.
22. Wolf JE Jr, Kaplan D, Kraus SJ, et al. Efficacy and tolerability of combined topical treatment of acne vulgaris with adapalene and clindamycin: a multicenter, randomized investigator-blinded study. J Am Acad Dermatol. 2003;49(suppl 3):S211-S217.
23. Cunliffe WJ, Meynadier J, Alirezai M, et al. Is combined oral and topical therapy better than oral therapy alone in patients with moderate to moderately severe acne vulgaris? a comparison of the efficacy and safety of lymecycline plus adapalene gel 0.1%, versus lymecycline plus gel vehicle. J Am Acad Dermatol. 2003;49(suppl 3): S218-S226.
24. Zhang J, Li L, Tu Y, et al. 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%. J Dermatoiog Treat. 2004;15:372-378.
25. Thiboutot DM, Weiss J, Bucko A, et al. Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study. J Am Acad Dermatol. 2007;57:791-799. Epub July 26, 2007.
26. Pariser DM, Westmoreland P, Morris A, et al. Longterm safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris. J Drugs Dermatol. 2007;6:899-905.