Titre du document / Document title

An observer-blind, parallel-group, randomized, multicentre clinical and microbiological study of a topical clindamycin/zinc gel and a topical clindamycin lotion in patients with mild/moderate acne

Auteur(s) / Author(s)

ZINDACLIN CLINICAL STUDY GROUP, ROYAUME-UNI
CUNLIFFE W. J. ⁽¹⁾ ; FERNANDEZ C. ⁽¹⁾ ; BOJAR R. ⁽¹⁾ ; KANIS R. ⁽²⁾ ; WEST F. ⁽²⁾ ;

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

⁽¹⁾ Skin Research Centre, Department of Dermatology, Leeds General Infirmary, Leeds, ROYAUME-UNI
⁽²⁾ Strakan Ltd, Buckholm Mill, Galashiels, ROYAUME-UNI

Résumé / Abstract

Introduction: A topical acne treatment in which clindamycin phosphate equivalent to 1% clindamycin is presented in a gel formulation has received marketing authorizations in a number of EU and non-EU countries. Clindamycin/zinc gel contains zinc acetate in a formulation that reduces systemic absorption of clindamycin through the skin. Objectives: To compare the efficacy and safety of a 1 % clindamycin/zinc gel when applied to the face once daily or twice daily with a 1 % clindamycin lotion applied twice daily for 16 weeks in patients with mild to moderate acne vulgaris. Methods: This was a randomized, comparative, observer-blind, parallel-group, multicentre study involving 246 acne patients. Results: The study demonstrated therapeutic similarity between clindamycin/zinc gel applied once and twice daily with clindamycin lotion applied twice daily. All three regimens produced a gradual and time-dependent reduction in inflamed lesions, non-inflamed lesions and overall grade. Side effects were similar and minimal, consisting predominantly of mild irritant dermatitis. All regimes produced a time-related significant reduction in skin surface and follicular Propionibacterium spp. and Micrococcaceae. The emergence of resistant strains was less than 5% and was similar with all three regimes. Conclusion: The equivalent efficacy and safety of clindamycin/zinc gel either once or twice daily to clindamycin lotion twice daily has been demonstrated. It is suggested that a treatment regime of one application per day may significantly enhance compliance and thus treatment success in acne patients.

Revue / Journal Title

Journal of dermatological treatment   ISSN 0954-6634 

Source / Source

2005, vol. 16, n^o4, pp. 213-218 [6 page(s) (article)] (13 ref.)

Langue / Language

Anglais

Editeur / Publisher

Taylor & Francis, Oslo, NORVEGE  (1989) (Revue)

Mots-clés anglais / English Keywords

Skin disease ; Dosage form ; Heavy metal ; Antibiotic ; Antibacterial agent ; Drug combination ; Treatment ; Comparative study ; Acne ; Human ; Lotion ; Colloidal gel ; Zinc ; Clindamycin ; Local administration ; Topical administration ; Randomization ;

Mots-clés français / French Keywords

Peau pathologie ; Forme pharmaceutique ; Métal lourd ; Antibiotique ; Antibactérien ; Association médicamenteuse ; Traitement ; Etude comparative ; Acné ; Homme ; Lotion ; Gel colloïdal ; Zinc ; Clindamycine ; Voie locale ; Voie externe ; Randomisation ;

Mots-clés espagnols / Spanish Keywords

Piel patología ; Forma farmacéutica ; Metal pesado ; Antibiótico ; Antibacteriano ; Asociación medicamentosa ; Tratamiento ; Estudio comparativo ; Acné ; Hombre ; Loción ; Gel coloidal ; Zinc ; Clindamicina ; Vía local ; Vía externa ; Aleatorización ;

Mots-clés d'auteur / Author Keywords

Acne ; clindamycin ; zinc ; topical ; gel ; lotion ;

Localisation / Location

INIST-CNRS, Cote INIST : 22488, 35400013200739.0030