A treatment for severe nodular acne: A randomized investigator-blinded, controlled, noninferiority trial comparing fixed-dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin

British Journal of Dermatology

Volumn 171, Issue 6, 2014, Pages 1508-1516

  Tan, J ^a   Humphrey, S ^b   Vender, R ^c   Barankin, B ^d   Gooderham, M ^e   Kerrouche, N ^f   Audibert, F ^f   Lynde, C ^g  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c Dermatrials Research   (Canada)

^d Toronto Centre   (Canada)

^e Skin Centre for Dermatology   (Canada)

^f Galderma R and D   (France)

^g Lynderm Clinical Research   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADAPALENE PLUS BENZOYL PEROXIDE; ALANINE AMINOTRANSFERASE; ANTIFUNGAL AGENT; ANTIINFECTIVE AGENT; ASPARTATE AMINOTRANSFERASE; CORTICOSTEROID; DOXYCYCLINE HYCLATE; ISOTRETINOIN; NONSTEROID ANTIINFLAMMATORY AGENT; TRIACYLGLYCEROL; ADAPALENE; BENZOYL PEROXIDE; DERMATOLOGICAL AGENT; DOXYCYCLINE; GEL; NAPHTHALENE DERIVATIVE;

ACNE; ADOLESCENT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CHEILITIS; CHILD; COMEDO; CONTROLLED STUDY; DECREASED APPETITE; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DRY LIP; DRY SKIN; DYSPEPSIA; FATIGUE; FEMALE; HALLUCINATION; HUMAN; HYPERCHOLESTEROLEMIA; INSOMNIA; INTENTION TO TREAT ANALYSIS; LIP DISEASE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NODULAR ACNE; PAPULE; PHOTOTOXICITY; PUSTULE; RANDOMIZED CONTROLLED TRIAL; SEVERE NODULAR ACNE; SIDE EFFECT; SKIN MANIFESTATION; STEVENS JOHNSON SYNDROME; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL; VOMITING; ACNE VULGARIS; CLINICAL TRIAL; COMPARATIVE STUDY; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; GEL; INTRADERMAL DRUG ADMINISTRATION; TREATMENT OUTCOME; YOUNG ADULT;

ACNE VULGARIS; ADMINISTRATION, CUTANEOUS; ADOLESCENT; ADULT; BENZOYL PEROXIDE; CHILD; DERMATOLOGIC AGENTS; DOUBLE-BLIND METHOD; DOXYCYCLINE; DRUG THERAPY, COMBINATION; FEMALE; GELS; HUMANS; ISOTRETINOIN; MALE; NAPHTHALENES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84919430411     PISSN: 00070963     EISSN: 13652133     Source Type: Journal    
DOI: 10.1111/bjd.13191     Document Type: Article

References (24)

1. Strauss JS, Krowchuk DP, Leyden JJ, et al,. Guidelines of care for acne vulgaris management. J Am Acad Dermatol 2007; 56: 651-63.
2. Dréno B, Bettoli V, Ochsendorf F, et al,. An expert view on the treatment of acne with systemic antibiotics and/or oral isotretinoin in the light of the new European recommendations. Eur J Dermatol 2006; 16: 565-71.
3. Layton AM, Dreno B, Gollnick HP, Zouboulis CC,. A review of the European Directive for prescribing systemic isotretinoin for acne vulgaris. J Eur Acad Dermatol Venereol 2006; 20: 773-6.
4. Gollnick H, Schramm M,. Topical drug treatment in acne. Dermatology 1998; 196: 119-25.
5. 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: 511-19.
6. Michel S, Jomard A, Demarchez M,. Pharmacology of adapalene. Br J Dermatol 1998; 139 (Suppl. 52): 3-7.
7. Shroot B, Michel S,. Pharmacology and chemistry of adapalene. J Am Acad Dermatol 1997; 36: S96-103.
8. Leyden JJ,. Current issues in antimicrobial therapy for the treatment of acne. J Eur Acad Dermatol Venereol 2001; 15 (Suppl. 3): S51-5.
9. Thiboutot DM, Weiss J, Bucko A, et al,. Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicentre, randomized double-blind, controlled study. J Am Acad Dermatol 2007; 57: 791-9.
10. Gollnick HP, Draelos Z, Glenn MJ, et al,. 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. Br J Dermatol 2009; 161: 1180-9.
11. Gold LS, Tan J, Cruz-Santana A, et al,. A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. Cutis 2009; 84: 110-16.
12. Pariser DM, Westmoreland P, Morris A, et al,. Long-term 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.
13. Tan J, Gollnick HP, Loesche C, et al,. Synergistic efficacy of adapalene 0.1%-benzoyl peroxide 2.5% in the treatment of 3855 acne vulgaris patients. J Dermatolog Treat 2011; 22: 197-205.
14. Feldman SR, Tan J, Poulin Y, et al,. The efficacy of adapalene-benzoyl peroxide combination increases with number of acne lesions. J Am Acad Dermatol 2011; 64: 1085-91.
15. Gold LS, Cruz A, Eichenfield L, et al,. Effective and safe combination therapy for severe acne vulgaris: a randomized, vehicle-controlled, double-blind study of adapalene 0.1%-benzoyl peroxide 2.5% fixed-dose combination gel with doxycycline hyclate 100 mg. Cutis 2010; 85: 94-104.
16. Lee WL, Shalita AR, Poh-Fitzpatrick MB,. Comparative studies of porphyrin production in Propionibacterium acnes and Propionibacterium granulosum. J Bacteriol 1978; 133: 811-15.
17. Ferreira-González I, Alonso-Coello P, Solà I, et al,. Composite endpoints in clinical trials. Rev Esp Cardiol 2008; 61: 283-90.
18. Gollnick HP, Graupe K, Zaumseil RP,. Comparison of combined azelaic acid cream plus oral minocycline with oral isotretinoin in severe acne. Eur J Dermatol 2001; 11: 538-44.
19. Oprica C, Emtestam L, Hagstromer L, Nord CE,. Clinical and microbiological comparisons of isotretinoin vs. tetracycline in acne vulgaris. Acta Derm Venereol 2007; 87: 246-54.
20. Pigatto PD, Finzi AF, Altomare GF, et al,. Isotretinoin versus minocycline in cystic acne: a study of lipid metabolism. Dermatologica 1986; 172: 154-9.
21. Lester RS, Schachter GD, Light MJ,. Isotretinoin and tetracycline in the management of severe nodulocystic acne. Int J Dermatol 1985; 24: 252-7.
22. Strauss JS, Leyden JJ, Lucky AW, et al,. Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: a randomized trial comparing micronized isotretinoin with standard isotretinoin. J Am Acad Dermatol 2001; 45: 196-207.
23. Center for Drug Evaluation and Research. FDA Clinical review 21-951 Cipher Pharmaceuticals Inc. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2012/021951Orig1s000MedR.pdf (last accessed 21 January 2014).
24. Ross S,. Composite outcomes in randomized clinical trials: arguments for and against. Am J Obstet Gynecol 2007; 196: 119 e1-6.