At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
EXC 001 +1 moredrug
Likely dose
Not stated in 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.
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS RESULTING FROM PRIOR BREAST SURGERY IN ADULT FEMALE SUBJECTS
In Brief
A Phase 2 clinical trial evaluating EXC 001 and Placebo for Scar Prevention. Completed, enrolled 25 participants across 5 sites.
Detailed Summary
This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScar Prevention
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedDec 2009
Primary CompletionApr 2010
TodayJul 2026
First PostedDec 23, 2009
Enrollment StartDec 22, 2009
Primary CompletionApr 9, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.5 years ago
Interventions
EXC 001drug
Multiple intradermal injections of EXC 001 and placebo
Placebodrug
Multiple intradermal injections of EXC 001 and placebo