|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
RPCEC |
|
Last refreshed on:
|
29 April 2013 |
|
Main ID: |
RPCEC00000062 |
|
Date of registration:
|
24/12/2010 |
|
Primary sponsor: |
|
|
Public title:
|
CIGB-128 administration to patients with surgically-treated keloids.
|
|
Scientific title:
|
CIGB-128 peri-incisional and peri-cicatricial administration to patients with surgically-treated keloids. |
|
Date of first enrolment:
|
13/11/2003 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Active |
|
URL:
|
http://registroclinico.sld.cu/trials/RPCEC00000062-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:
|
Tania
Gonzalez Lopez |
|
Address:
|
Ave. 31 entre 158 y 190, Reparto Cuabanacan, Playa
6162
Havana City
Cuba |
|
Telephone:
|
(53-7)- 2087379 (53-7)- 2087465 (53-7)- 208 7421 |
|
Email:
|
tania.gonzalez@cigb.edu.cu |
|
Affiliation:
|
Center for Genetic Engineering and Biotechnology (CIGB) |
|
|
Name:
|
Tania -------------------------------------------------- Teléfono (para inquietudes científicas):
Gonzalez Lopez |
|
Address:
|
Ave. 31 entre 158 y 190, Reparto Cuabanacan, Playa
6162
Havana City
Cuba |
|
Telephone:
|
(53-7)- 2087379 (53-7)- 2087465 (53-7)- 208 7421 |
|
Email:
|
tania.gonzalez@cigb.edu.cu |
|
Affiliation:
|
Center for Genetic Engineering and Biotechnology (CIGB) |
| |
|
Key inclusion & exclusion 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: 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
Age minimum:
1 year
Age maximum:
18 years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Keloids
|
|
Intervention(s)
|
|
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.
|
|
Primary Outcome(s)
|
|
Relapse: during treatment and during one year follow-up.
|
|
Secondary Outcome(s)
|
|
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.
|
|
Secondary ID(s)
|
|
IG/IAI-IGI/QL/0301
|
|
Source(s) of Monetary Support
|
|
Center for Genetic Engineering and Biotechnology (CIGB) Ministry of Public Health, CUBA
|
|