CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
AZX100 Drug Product +2 moredrug
Likely dose
AZX100 Drug Product 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00825916
NCT00825916Phase 2Completed
CompareCT.gov

A Pilot Phase 2a Blinded, Placebo Controlled, Multicenter Parallel Group, Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of AZX100 Drug Product Following Excision of Keloids

Capstone Therapeutics·interventional·Posted Jan 21, 2009·Updated Oct 11, 2012

In Brief

A Phase 2 clinical trial evaluating AZX100 Drug Product and Placebo for Scar Prevention and Scar Reduction. Completed, enrolled 59 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScar Prevention, Scar Reduction
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.4 years ago

Interventions

AZX100 Drug Productdrug

Subjects were administered AZX100 3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.

AZX100 Drug Productdrug

Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.

Placebodrug

Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.