Application of CIGB-128 in keloid patients undergoing surgical exeresis.

Phase 2

• Conditions: Keloids; Keloid/surgery; Cicatrix; Granulation Tissue; Connective Tissue; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes

• Registration Number: RPCEC00000061
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.