Keloids
Conditions
Interventions
Patients are treated with CIGB-128 and/or placebo by injection of product around the wound following the surgical lesion exeresis and before suturing (first administration), and 15 days after surgery
Interferon-alpha
Placebos
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Age between 1 and 18 years. 2) Clinical diagnosis: Keloid of traumatic etiology. 3) Lesion size between 0.5 and 10 cm. 4) Consent in writing signed by the patient and his/her legal guardians. 5) Six-month untreated lesions before inclusion.
Exclusion criteria
Exclusion criteria: 1. Post-burn keloid. 2. Hypertrophic scars. 3. Pregnancy, puerperium or breastfeeding. 4. Hypersensitivity to CIGB-128 or any other preparation used in the study, or any other compound derived from genetic engineering products. 5. Decompensated chronic diseases (ischemic heart disease, diabetes mellitus, and renal failure). 6. Patients who underwent antifibrotic treatment for the last 6 months before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse: during treatment and during one year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time until relapse: Evaluation every 3 months and up to 1 year. Esthetic results of treatment: GOOD, FAIR OR BAD cicatrisation upon treatment or after one year. | — |
Countries
Cuba
Contacts
Public ContactTania Gonzalez Lopez
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed