A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars

Summary

The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.

Timeline

Start

2009-03

Primary completion

2010-07

Completion

2010-07

Outcome

Missed primary endpoint

registry PSAS Results for Placebo vs PSAS Results for 3 mg AZX100; p = 0.078; Wilcoxon (rank sum) NCT00825916 ↗

registry PSAS Results for Placebo vs PSAS Results for 10 mg AZX100; p = 0.086; Wilcoxon (rank sum) NCT00825916 ↗

registry OSAS Results for Placebo vs OSAS Results for 3 mg AZX100; p = 0.92; Wilcoxon (rank sum) NCT00825916 ↗

registry OSAS Results for Placebo vs OSAS Results for 10 mg AZX100; p = 0.49; Wilcoxon (rank sum) NCT00825916 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZX100	Unknown	3 mg	Other
Subject	AZX100	Unknown	10 mg	Other

Indications