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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000061
• Date of registration: 24/12/2010
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB)
• Public title: Application of CIGB-128 in keloid patients undergoing surgical exeresis.
• Scientific title: Application of CIGB-128 in keloid patients undergoing surgical exeresis.
• Date of first enrolment: 02/04/2004
• Target sample size: 45
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000061-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Ena Infante Cristia
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB)

• Name: Dra. Ena Infante Cristia
• Affiliation: Center for Genetic Engineering and Biotechnology. (CIGB)

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

Keloids

Intervention(s)

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, before wounds are occluded, at the edges and the bottom of the surgical wound, at a dose of 1 mL per linear cm of scar. There will be a second application 21 days later in all patients groups and in the Triamcinolone group only if there are clinical signs of scar hypertrophy. Groups I y II will be treated with CIGB-128 and/or placebo. Group III will be treated with Triamcinolone at a dose of 40 mg/ml. Surgery will be performed at the outpatient operating room in participating institutions. The other treatment applications will be conducted at Dermatology Outpatients of Hermanos Ameijeiras Hospital or at the Reconstructive Surgery Department of Calixto García Hospital, as appropriate. Applications will be indicated on control cards developed for this purpose

Primary Outcome(s)

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 Outcome(s)

-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.

Secondary ID(s)

IG/IAI-IGI/QL/0302

Source(s) of Monetary Support

Heber Biotec S.A.

Secondary Sponsor(s)

Not applicable