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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

CIGB-128 peri-incisional and peri-cicatricial administration to patients with surgically-treated keloids.

Secondary indentifying numbers:

IG/IAI-IGI/QL/0301

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB) Ministry of Public Health, CUBA

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

22/10/2003

Reference number:

637/05.010.03B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Dadonin

Last name:

Vila Morales

Medical Specialty :

2nd Degree Specialist in Maxillofacial Surgery

Affiliation:

''Juan Manuel Marquez'' Hospital

Postal address:

Avenida 31 e/. 76 y 100

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

+53-72602860

Email address:

dadonim.vila@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

“Juan Manuel Marquez” Hospital, March 24, 2003

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

13/11/2003

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Keloids

Health condition(s) code:

Keloid/surgery

Cicatrix

Granulation Tissue

Connective Tissue

Collagen Diseases

Connective Tissue Diseases

Skin and Connective Tissue Diseases

Fibrosis

Pathologic Processes

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.

Intervention code:

Interferon-alpha

Interferon-gamma

Interferons

Injections, Intralesional

Dermatologic Surgical Procedures

Placebos

Intervention keyword:

CIGB-128

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Relapse: during treatment and during one year follow-up.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

1 year

Maximum age:

18 years

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

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Tania

Last Name:

Gonzalez Lopez

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Reparto Cuabanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2087379 (53-7)- 2087465 (53-7)- 208 7421

Email :

tania.gonzalez@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Tania

Last Name:

Gonzalez Lopez

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Reparto Cuabanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2087379 (53-7)- 2087465 (53-7)- 208 7421

Email :

tania.gonzalez@cigb.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000062

Date of Registration in Primary Registry:

2010-12-24

Record Verification Date:

2008-06-09 20:00

Link to the spanish version:

Click here [3]