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NCT01346969 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
68
Enrollment target

NCT01346969: Completed Phase 2 study, sponsored by Pfizer.

NCT01346969 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01346969, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
68 participants
Enrollment target

Study 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.

Primary Outcome

Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participa

Interventions

  • DRUG EXC 001

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2011-06-01
Est. Completion 2012-04-16
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT01346969 record still lists

NCT01346969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).

The record links to 0 conditions, and to 1 intervention - of which EXC 001 is the first listed.

NCT01346969 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01346969 about?

NCT01346969 is a clinical study titled "Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery". 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.

What is the current status of trial NCT01346969?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2011-06-01. Estimated completion is 2012-04-16.

What interventions are being tested in trial NCT01346969?

The interventions under investigation include: EXC 001 (DRUG).

Who is sponsoring clinical trial NCT01346969?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01346969's enrollment target sits among peer trials

68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01346969, the US trial registry maintained by the National Library of Medicine. NCT01346969 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.