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

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:

Secondary indentifying numbers:

IG/IAI-IGI/QL/0302

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Heber Biotec S.A.

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:

638/05.016.038

Principal investigator

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

First name:

Sonia

Last name:

Collazo Caballero

Medical Specialty :

Specialist 2nd. Degree in Dermatology

Affiliation:

"Hermanos Ameijeiras" Hospital

Postal address:

San Lázaro 701 corner Belascoain

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

Email address:

email@not.entered [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:

Havana. ''Calixto Garcia Inniguez'' Hospital, Dr. Alberto Cuza Torres.

Research ethics committees:

“Hermanos Ameijeiras” Hospital, April, 07, 2003.

modification 01: March 15, 2005. “Calixto Garcia Iñiguez” Hospital, March 14, 2005.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

02/04/2004

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 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

Intervention code:

Interferon-alpha

Interferon-gamma

Triamcinolone

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: 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.

Key secondary outcomes:

-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.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

75 years

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.

Type of population:

Adults

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:

Ena

Last Name:

Infante Cristia

Specialty:

Specialist 2nd. Degree in Dermatology

Affiliation:

Center for Genetic Engineering and Biotechnology. (CIGB)

Postal Address:

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

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

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

Email :

ena.infante@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:

Ena

Last Name:

Infante Cristia

Specialty:

Specialist 2nd. Degree in Dermatology

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

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

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

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

Email :

ena.infante@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:

RPCEC00000061

Date of Registration in Primary Registry:

2010-12-24

Record Verification Date:

2008-06-04 20:00

Link to the spanish version:

Click here [3]