Treatment of post-surgical scars using CACIPLIQ20
Post-surgical Scars After the Use of CACIPLIQ20: A Randomized, Double-blind, Placebo -Controlled Trial
This study is testing if a new device called CACIPLIQ20 can help improve the appearance of scars after breast surgery in women.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Organ, Tissue, Regeneration, Repair and Replacement Industry-sponsored |
| Locations | 2 sites (Brest, Bretagne and 1 other locations) |
| Trial ID | NCT05528328 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of CACIPLIQ20, a medical device designed to improve the appearance of scars following bilateral mammoplasty for breast hypertrophy. The study is a double-blind, placebo-controlled, self-controlled trial involving 50 female patients, where one breast will receive CACIPLIQ20 and the other a placebo. The primary outcome will be assessed at 24 weeks using a global scar comparison scale, with standardized photographs taken at multiple intervals to document scar progression. The trial will take place across three centers in France over an estimated duration of 6 months per participant.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 85 scheduled for bilateral breast reduction surgery using the conventional superior pedicle technique.
Not a fit: Patients who are pregnant, lactating, or have a history of previous breast surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the aesthetic outcomes of surgical scars for patients undergoing breast reduction.
How similar studies have performed: Other studies using similar regenerative agents have shown promise, but this specific application of CACIPLIQ20 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients scheduled for bilateral breast reduction (\>300 g by breast) using the conventional superior pedicle technique with inverted-T scars 2. Age between 18 and 85 years 3. Patients having received a full written and oral information about study conduct and objectives 4. Patients who can and are willing to be followed by the study investigator for the duration of the study 5. Patients benefiting from a valid health insurance or social security coverage Exclusion Criteria: 1. Female patients who are pregnant, or lactating 2. Patients with, according to investigator's opinion, a very poor life expectancy 3. Patients intolerant to one of the study device components or to heparinoids 4. Any scar treatment other than the standard of care 5. Previous breast surgery 6. Current malignancy
Where this trial is running
Brest, Bretagne and 1 other locations
- CHU Brest — Brest, Bretagne, France (Recruiting)
- Clinique Turin — Paris, Ile De France, France (Recruiting)
Study contacts
- Principal investigator: Gilbert Zakine — Clinique Turin
- Study coordinator: Frederic Sedel, MD, PhD
- Email: frederic.sedel@otr3.com
- Phone: +33 (0)1 83627895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.