Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects.

Phase 1/2 Completed 42 enrolled Renovo

RandomizedSingle-groupQuadruple-blindBasic science

Summary

An exploratory Phase-II trial with intradermal RN1001 (Avotermin) to investigate scar prevention and reduction and acceleration of healing. The trial has an additional objective to evaluate several different scar assessment techniques that can be used in future clinical trials in the prevention and reduction of scarring.

Timeline

Start: 2002-09
Primary completion: 2003-06
Completion: 2003-06

Publications

Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avotermin	Protein / enzyme biologic	5 ng	Intramuscular
Subject	Avotermin	Protein / enzyme biologic	50 ng	Intramuscular
Subject	Avotermin	Protein / enzyme biologic	100 ng	Intramuscular

Indications

No indication recorded.