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NCT04331080 · ClinicalTrials.gov registry record · Phase 2
A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery
A Phase 2 study of Breast Reconstruction and Scar, sponsored by Xequel Bio.
- Completed
- Registry status
- Phase 2
- Development phase
- 184
- Enrollment target
- 11
- Study locations
NCT04331080: Completed Phase 2 study of Breast Reconstruction and Scar, sponsored by Xequel Bio.
NCT04331080 is a Phase 2 study of Breast Reconstruction and Scar that has completed, run by Xequel Bio. The registered enrollment target is 184 participants, below the 384-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (52% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04331080, a Phase 2 study of Breast Reconstruction and Scar, has completed, sponsored by Xequel Bio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 184 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
Primary Outcome
Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a rage from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score.
Conditions Studied
Interventions
- DRUG Vehicle gel
- DRUG Granexin® gel 100 μM
- DRUG Granexin® gel 200 μM
Study Locations (11)
Florida
- Universal Axon Clinical Research - Doral
- Miami Plastic Surgery - Miami
- Ibrahim H. Amjad, MD, PA - West Miami
California
- Private Clinic- David Kulber - Los Angeles
- Pasadena Surgeons - Pasadena
Illinois
- Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery - Chicago
Iowa
- Iowa Plastic Surgery - Davenport
New York
- Luxurgery - New York
North Carolina
- Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery - Winston-Salem
Texas
- Integrated Aesthetics - Spring
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2022-05-26 |
| Phase | Phase 2 |
What the finished NCT04331080 record still lists
NCT04331080 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 384-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (52% lower).
The record links to 4 conditions, with Breast Reconstruction appearing as the primary indexed condition, and to 3 interventions - of which Vehicle gel is the first listed.
NCT04331080 lists 11 locations in 8 states (Florida, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT04331080 about?
NCT04331080 is a clinical study titled "A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery". The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
What is the current status of trial NCT04331080?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2020-07-01. Estimated completion is 2022-05-26.
What conditions does trial NCT04331080 study?
This clinical trial studies the following conditions: Breast Reconstruction, Scar, Scarring, Mammoplasty.
What interventions are being tested in trial NCT04331080?
The interventions under investigation include: Vehicle gel (DRUG), Granexin® gel 100 μM (DRUG), Granexin® gel 200 μM (DRUG).
Who is sponsoring clinical trial NCT04331080?
This trial is sponsored by Xequel Bio, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04331080 being conducted?
This trial has 11 study locations across California, Florida, Illinois, Iowa, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Reconstruction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04331080's enrollment target sits among peer trials
184 10th of 18 higher than 9 of 18 other Breast Reconstruction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Reconstruction 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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