Improved risk-benefit ratio for topical triamcinolone acetonide in Transfersome in comparison with equipotent cream and ointment: a randomized controlled trial.
Br J Dermatol
; 149(3): 611-9, 2003 Sep.
Article
em En
| MEDLINE
| ID: mdl-14510997
ABSTRACT
BACKGROUND:
Transfersome is a drug delivery technology based on highly deformable, ultraflexible lipid vesicles which penetrate the skin when applied non-occlusively.OBJECTIVES:
To assess the advantages of this carrier-based formulation in humans, the efficacy and the atrophogenic potential of triamcinolone acetonide (TAC) in Transfersome was compared with commercially available TAC-containing cream and ointment.METHODS:
Healthy volunteers were enrolled in double-blind, placebo-controlled clinical trials with random study medication assignment to the test areas.RESULTS:
A 10-fold lower dose of TAC in Transfersome(R) (2.5 micro g cm-2) was bioequivalent to 25 micro g cm-2 TAC in conventional formulations as measured by erythema suppression (cream P = 0.01, ointment P < 0.001). A skin blanching assay revealed different kinetics of the formulations, with a delayed onset of action of the Transfersome and ointment preparations. Ultrasonic measurements revealed a significantly reduced atrophogenic potential. There was a 12.1% reduction in skin thickness given by TAC in Transfersome compared with a 21.1% reduction given by a bioequivalent dose in TAC cream after a 6-week treatment period (P = 0.007).CONCLUSIONS:
Transfersome may significantly improve the risk-benefit ratio of topically applied glucocorticosteroids.
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Temas:
ECOS
/
Equidade_desigualdade
Bases de dados:
MEDLINE
Assunto principal:
Pele
/
Triancinolona Acetonida
/
Portadores de Fármacos
/
Anti-Inflamatórios
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Aspecto:
Equity_inequality
Limite:
Adult
/
Humans
/
Middle aged
Idioma:
En
Revista:
Br J Dermatol
Ano de publicação:
2003
Tipo de documento:
Article
País de afiliação:
Alemanha