Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials - 11/09/11

Doi : 10.1016/S0190-9622(97)70056-2

W.J. Cunliffe, MD, R. Caputo, MD, B. Dreno, MD, L. Förström, MD, M. Heenen, MD, C.E. Orfanos, MD, Y. Privat, MD, A.Robledo Aguilar, MD, J. Meynadier, Mohsen Alirezai, MD, S. Jablonska, MD, A. Shalita, MD, J.S. Weiss, MD, D.K. Chalker, MD, C.N. Ellis, MD, A. Greenspan, MD, H.I. Katz, MD, I. Kantor, MD, L.E. Millikan, MD, J.M. Swinehart, MD, L. Swinyer, MD, C. Whitmore, MD, J. Czernielewski, MD, M. Verschoore, MD
Leeds, United Kingdom; Milano, Italy; Nantes, Aixen Provence, Montpellier, and Levallois-Perret, France; Helsinki, Finland; Brussels, Belgium; Berlin, Germany; Madrid, Spain; Warsaw, Poland; Brooklyn, Port Chester and Great Neck, New York; Atlanta and Augusta, Georgia; Ann Arbor, Michigan; Maywood, New Jersey; Fridley, Minnesota; New Orleans, Louisiana; Denver, Colorado; Salt Lake City, Utah; and Lynchburg, Virginia
General Infirmary, Leeds; the Instituto di Scienze Dermatologiche, Milano; the Service de Dermatologie, Hôtel Dieu,Nantes; Department of Dermatology, University Central Hospital, Helsinki; the Service de Dermatologie, Hôpital Erasme, Brussels; the Department of Dermatology, University Medical Center Benjamin Franklin, Berlin; the Centre Carnot Forbin, Aix en Provence; the Catedratico de Dermatologia, the Hospital Clinico Universitario, Madrid; the Clinique de Dermatologie, C.H.U. de Montpellier, Hôpital Saint Charles, Montpellier; the Klinika Dermatologiczna A.M., Warsaw; the SUNY Health Science Center, Brooklyn, and the International Research Services, Port Chester; Emory University, Atlanta; Medical College of Georgia, Augusta; the University of Michigan, Ann Arbor; TKL Research, Maywood; the Minnesota Clinical Study Center, Fridley; the Research Testing Laboratories, Inc., Great Neck; Tulane University New Orleans; Colorado Medical Research Center, Denver; Salt Lake City; the Education and Research Foundation, Lynchburg; and the Laboratoires Galderma, Levallois-Perret

Abstract

Background: Adapalene is a new chemical entity that exhibits tretinoin-like activities in the terminal differentiation process.

Objective: We evaluated a dose range effect of two concentrations of adapalene gel as acne treatment and compared adapalene 0.1% gel with tretinoin 0.025% gel in the treatment of acne patients in two large multicenter studies.

Methods: Multicenter, investigator-masked, parallel group studies including 89 acne patients in the dose range study and 591 patients in the concurrent controlled studies were conducted.

Results: Adapalene gel 0.1% was significantly more effective in treating acne lesions than 0.03% adapalene gel. Adapalene gel 0.1% was significantly more effective than 0.025% or tretinoin gel in one study and of the same effectiveness in the other study. Adapalene gel was always better tolerated than tretinoin gel.

Conclusion: Adapalene 0.1% gel is a safe and effective treatment of acne vulgaris. (J Am Acad Dermatol 1997;36:S126-34.)

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Plan

DOSE RANGE STUDY: STUDY I

CONCURRENT CONTROLLED STUDIES

RESULTS: STUDIES I, II, III

1) Study I: Dose range study results

2) Study II: Adapalene 0.1% versus tretinoin multicenter controlled study (U.S. study) ^{Shalita A, Weiss JS, Chalker DK, et al. A comparison of the efficacy and safety of adapalene gel 0.1% and tretinoin gel 0.025% in the treatment of acne vulgaris: A multicenter trial J Am Acad Dermatol 1996 ; 34 : 482-485}

3) Study III: Adapalene 0.1% versus tretinoin multicenter controlled study (European study)

DISCUSSION

	Reprint requests: M. Verschoore, MD, Laboratoires Galderma, 20 Avenue André Malraux, 92309 Levallois-Perret Cedex, France.
	0190-9622/97/$5.00 + 0 16/0/81181

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Vol 36 - N° 6S

P. S126-S134 - juin 1997 Retour au numéro

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Skin distribution and pharmaceutical aspects of adapalene gel
Josiane Allec, Alain Chatelus, Nathalie Wagner, From CIRD Galderma, Sophia Antipolis.

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Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials - 11/09/11

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