Improved risk-benefit ratio for topical triamcinolone acetonide in Transfersome in comparison with equipotent cream and ointment: a randomized controlled trial.
BACKGROUND
Transfersome is a drug delivery technology based on highly deformable, ultraflexible lipid vesicles which penetrate the skin when applied non-occlusively.


OBJECTIVE
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.
D000287:Administration, Topical; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001284:Atrophy / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004337:Drug Carriers; D004643:Emollients; D006801:Humans; D008055:Lipids; D008875:Middle Aged; D016017:Odds Ratio; D009824:Ointments; D018570:Risk Assessment; D012867:Skin / Q000473:pathology*; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects
D000893:Anti-Inflammatory Agents; D004337:Drug Carriers; D004643:Emollients; D008055:Lipids; D009824:Ointments; D014222:Triamcinolone Acetonide