Using CACIPLIQ20 to improve wound healing in children with Epidermolysis Bullosa
A Randomized, Double-Blind, Placebo-Controlled, Crossover, Pilot Stage Clinical Trial Evaluating CACIPLIQ20 in Wound Healing in Subjects With Epidermolysis Bullosa
This study is testing if a new treatment called CACIPLIQ20 can help children with Epidermolysis Bullosa heal their wounds better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Organ, Tissue, Regeneration, Repair and Replacement Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT06007235 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of CACIPLIQ20 in promoting wound healing in pediatric patients diagnosed with Dystrophic or Junctional Epidermolysis Bullosa (EB). Participants aged 3 to 18 years with at least one active wound will be randomly assigned to receive either CACIPLIQ20 or a placebo in a crossover design, with treatment periods lasting one month each. The study aims to assess the healing effects of CACIPLIQ20 compared to standard care, with patients monitored through multiple visits over the course of the trial. The treatment will be administered every 3 to 4 days, and both patients and investigators will remain blinded to the treatment allocation.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 18 years with a confirmed diagnosis of Dystrophic or Junctional Epidermolysis Bullosa and at least one active wound.
Not a fit: Patients with a history of malignancy, those currently pregnant or breastfeeding, or individuals who have used investigational drugs recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance wound healing and improve the quality of life for patients suffering from Epidermolysis Bullosa.
How similar studies have performed: While there have been various approaches to treating Epidermolysis Bullosa, the specific use of CACIPLIQ20 in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Dystrophic or Junctional EB. * 3 years ≤ age ≤ 18 years * At least one active wound at inclusion * Informed consent form signed by the patient's legal representative; if the patient is minor but capable of providing consent, additional signed consent from the patient. * Patient and caregiver must be willing to comply with all protocol requirements. Exclusion Criteria: * Use of any investigational drug within the last 30 days before enrolment. * Current or former malignancy. * Pregnancy or breastfeeding during the study. * Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception. * Use of CACIPLIQ20 within the last 30 days before enrolment. * Patients intolerant to one of the study device components or to heparinoids.
Where this trial is running
Paris
- Hopital Necker - enfants malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Christine Bodemer, MD, PhD — Hopital Necker - enfants malades
- 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.