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- Titel:
Improved risk-benefit ratio for topical triamcinolone acetonide in Transfersome in comparison with equipotent cream and ointment: a randomized controlled trial.
- Dokumenttyp:
- Clinical Trial; Journal Article; Randomized Controlled Trial; Article
- Autor(en):
- Fesq, H; Lehmann, J; Kontny, A; Erdmann, I; Theiling, K; Röther, M; Ring, J; Cevc, G; Abeck, D
- 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.
- Zeitschriftentitel:
- Br J Dermatol
- Jahr:
- 2003
- Band / Volume:
- 149
- Heft / Issue:
- 3
- Seitenangaben Beitrag:
- 611-9
- Sprache:
- eng
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/14510997
- Print-ISSN:
- 0007-0963
- TUM Einrichtung:
- Klinik und Poliklinik für Dermatologie und Allergologie
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