Titre du document / Document title

Tretinoin cream 0.02% for the treatment of photodamaged facial skin : A review of 2 double-blind clinical studies

Auteur(s) / Author(s)

NYIRADY Judit ⁽¹⁾ ; BERGFELD Wilma ⁽²⁾ ; ELLIS Charles ⁽³⁾ ; LEVINE Norman ⁽⁴⁾ ; SAVIN Ronald ⁽⁵⁾ ; SHAVIN Joel ⁽⁶⁾ ; VOORHEES John J. ⁽³⁾ ; WEISS Jonathan ⁽⁷⁾ ; GROSSMAN Rachel ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Johnson & Johnson Consumer Products Worldwide, Skillman, New Jersey, ETATS-UNIS
⁽²⁾ Cleveland Clinic Foundation, Cleveland, Ohio, ETATS-UNIS
⁽³⁾ University of Michigan Medical Center, Ann Arbor, ETATS-UNIS
⁽⁴⁾ University of Arizona Health Sciences Center, Tucson, ETATS-UNIS
⁽⁵⁾ Adult & Adolescent Dermatology, PC, New Haven, Connecticut, ETATS-UNIS
⁽⁶⁾ Gwinnet Clinical Research Center, Snellville, Georgia, ETATS-UNIS
⁽⁷⁾ Emory Clinic, Atlanta, Georgia, ETATS-UNIS

Résumé / Abstract

In extensive clinical studies and practical use since its US Food and Drug Administration approval in 1995, tretinoin emollient cream 0.05% has been shown to be safe and effective in the treatment of fine facial wrinkles, mottled hyperpigmentation, and skin roughness. To provide additional prescribing flexibility for various patient needs, a new lower concentration formulation, tretinoin cream 0.02% was chosen for further development. Two multicenter, randomized, double-blind, vehicle-controlled clinical studies were conducted to evaluate the safety and efficacy of the lower concentration tretinoin formulation in the treatment of moderate-to-severe facial photodamage. Results indicate statistically significant improvement in fine wrinkling, coarse wrinkling, and yellowing with the use of tretinoin cream 0.02% at week-24 end point, compared with placebo. Therapy with tretinoin cream 0.02% was well tolerated overall and demonstrated a favorable safety profile Both studies demonstrated that tretinoin cream 0.02% is safe and effective for the treatment of moderate-to-severe photodamaged facial skin.

Revue / Journal Title

Cutis   ISSN 0011-4162   CODEN CUTIBC 

Source / Source

2001, vol. 68, n^o2, pp. 135-142 (12 ref.)

Langue / Language

Anglais

Editeur / Publisher

Quadrant HealthCom, Chatham, NJ, ETATS-UNIS  (1965) (Revue)

Mots-clés anglais / English Keywords

Tretinoin ; Local administration ; Treatment ; Face ; Skin ; Photodermatosis ; Ageing ; Percutaneous route ; Human ; Double blind study ; Retinoid ; Skin disease ; Photosensitivity ;

Mots-clés français / French Keywords

Trétinoïne ; Voie locale ; Traitement ; Face ; Peau ; Photodermatose ; Vieillissement ; Voie percutanée ; Homme ; Etude double insu ; Rétinoïde ; Peau pathologie ; Photosensibilité ;

Mots-clés espagnols / Spanish Keywords

Tretinoína ; Vía local ; Tratamiento ; Cara ; Piel ; Fotodermatosis ; Envejecimiento ; Vía percutánea ; Hombre ; Estudio doble ciego ; Retinoide ; Piel patología ; Fotosensibilidad ;

Localisation / Location

INIST-CNRS, Cote INIST : 17068, 35400009940801.0130