Keloids
Conditions
Interventions
Patients will be treated with the product to be injected at the edges of the wound after surgical exeresis is performed and by pericicatricial (PC) route. It will be first applied during the operation
Interferon-alpha
Triamcinolone
Placebos
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 75. 2) Lesions on any location, regardless of progression time. 3) Patient’s consent in writing. 4) Clinical and histological diagnosis. 5) Lesion size ranging from 0.5 to 10 cm. 6) No antifibrotic treatment up to 6 months before inclusion.
Exclusion criteria
Exclusion criteria: Hypertrophic scars. Pregnancy or breastfeeding. Hypersensitivity to CIGB-128 or other preparations used in the study. Acute or chronic liver condition (twice the normal TGP and TGO values and/or total bilirubin >17 micromol/L). Acute or chronic kidney condition. Uncontrolled heart failure. Severe hematological disorders. Severe psychiatric disorder or any other condition preventing the patient from giving consent or making it difficult to conduct evaluations. Diabetes mellitus. Patients who have been on any other antifibrotic treatment in the last 6 months before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse: Clinical characteristics will be observed and lesion size will be measured before surgical exeresis is performed. Scars will be assessed on a weekly basis during 21 days after surgery and on a quarterly basis for one year (follow-up) to detect relapses. The following categories will be considered: - Satisfactory response: No clinical signs of keloids (relapses) over treatment and follow-up periods. – Non satisfactory response: Clinical signs of keloids (relapses) over treatment or follow-up period. A satisfactory response will be considered a success and a non satisfactory response, a failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Relapse time: Period of time between the first day following surgical exeresis and the occurrence of a clinically demonstrated lesion in the area under treatment. Follow-up evaluations will be made during one year after treatment. – Esthetic results of treatment according to aftereffects: They will be measured upon treatment completion and during final evaluation (at the end of one-year follow-up). Consideration will be given to the following elements: Color: normochromia, hyperchromia (slight, moderate or severe), hypochromia (slight, moderate or severe), achromia. Volume: flat, hypertrophy (slight, moderate or severe), keloid, atrophy (slight, moderate or severe). Tactile sensitivity: normal, hyperesthesia (slight, moderate or severe), hypoesthesia (slight, moderate or severe), anesthesia. Spontaneous pain, itching. – Ratio of patients with adverse reactions: From the total number of patients on treatment, the percentage of those developing adverse reactions like antibody formation will be calculated. Out of them, the number of patients exhibiting neutralizing activity will be calculated. | — |
Countries
Cuba
Contacts
Public ContactEna Infante Cristia
Center for Genetic Engineering and Biotechnology. (CIGB)
Outcome results
None listed