CIGB-128 administration to patients with surgically-treated keloids.

Authors
Category Primary study
Registry of TrialsRegistro Público Cubano de Ensayos Clínicos
Year 2010
INTERVENTION: CIGB‐128 Interferon‐alpha 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 by peri‐cicatricial route twice a week for 4 consecutive weeks. Afterwards, the product will be administered once a week for another 4 weeks. CONDITION: Keloid/surgery Keloids PRIMARY OUTCOME: Relapse: during treatment and during one year follow‐up. SECONDARY OUTCOME: 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. 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.
Epistemonikos ID: ee653ab1b87897d9e55469a092db790306169777
First added on: Aug 22, 2024