CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
EXC 001 +3 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.

Search/NCT01346969
NCT01346969Phase 2Completed
CompareCT.gov

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)

Pfizer·interventional·Posted May 4, 2011·Updated Sep 9, 2021

In Brief

A Phase 2 clinical trial evaluating EXC 001 for Reduction in Hypertrophic Skin Scarring. Completed, enrolled 68 participants across 12 sites.

Detailed Summary

The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsReduction in Hypertrophic Skin Scarring
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2011
Enrollment StartJun 1, 2011
Primary CompletionApr 16, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.2 years ago

Interventions

EXC 001drug

Single-dose administered by injection four different times

EXC 001drug

Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1

EXC 001drug

Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2

EXC 001drug

Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3