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Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

NCT01346969 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-09-09

Study results available
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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.

Conditions

  • Reduction in Hypertrophic Skin Scarring

Interventions

DRUG

EXC 001

Single-dose administered by injection four different times

DRUG

EXC 001

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

DRUG

EXC 001

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

DRUG

EXC 001

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-01
Primary Completion
2012-04-16
Completion
2012-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01346969 on ClinicalTrials.gov