EGFpeeling I

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:

“Human Recombinant Epidermal Growth Factor to accelerate the healing after chemical peels”.

Secondary indentifying numbers:

IG/FCG/PQ/0701

Issuing authority of the secondary identifying numbers:

CIGB

Source(s) of monetary or material support:

Heber Biotec S.A. Cuban Ministry of Public Health.

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 :

15/04/2008

Reference number:

05-003-08-B

Principal investigator

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

First name:

Migdalia Lugo Izquierdo MD.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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:

Rafael Valdés Menéndez University Polyclinic, January 10, 2008.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

30/07/2008

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:

Acne scarring, melasm, or other injuries that require chemical peeling.

Intervention(s):

Group I experimental: Will peelings 1-3 sets of media to the application of trichloroacetic acid (ATA) to 20% in the facial region with intervals of 15-21 days, followed by topical administration of the test product (viscous solution of 1% carboxymethylcellulose additive of EGF 10 ug / mL) twice daily. Group II control: Will peelings 1-3 sets of media to the application of trichloroacetic acid (ATA) to 20% in the facial region with intervals of 15-21 days, followed by topical administration of the placebo (carboxymethylcellulose viscous solution of 1%) twice daily.

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):

Time to healing, 1 month after treatment.

Key secondary outcomes:

Quality of healing, one year after treatment. Adverse events during the period for completion of media peels, a month after treatment and follow-up a 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:

20 years

Maximum age:

N/A (No limit)

Inclusion criteria:

1.Informed consent. 2.Age major than 20 years old, both sexes. 3.Skin diseases that affect facial aesthetics and require peel. 4.Fitzpatrick skin type classification I to IV.

Exclusion criteria:

1.Active lesions of acne vulgaris that require treatment or patient with them in the last 6 months. 2.Fitzpatrick skin type classification V-VI. 3.Infection requiring antibiotic treatment or active herpes virus infection. 4.Another skin disease affecting the face. For example: neurotic excoriation. 5.Personal history of keloids or others defect of healing. 6.Diabetes mellitus, erythematosus lupus or some others systemic disease that concern general compliance (liver disease, renal disease, pancreatic disease, colagenosis, anemia, etc.). 7.Malignancies (except the basal cell carcinoma and the cervix cancer in situ after surgery and complete cured). 8.Serious hypertension or heart disease. 9.Previous treatment with steroids in the last 3 months. 10.Previous treatment with EGF in the last 30 days. 11.Previous treatment in the last 6 months like this: isotretinoin, chemical peels, aesthetic or surgical procedure of the head or neck. 12.Serious psychiatric disorder and other disease that limit informed consent. 13.Patient exposed to ultraviolet radiation due to their occupation. 14.Pregnancy and lactation.

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:

2

Target sample size:

30

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:

Dr. Pedro

Middle Name:

Antonio

Last Name:

López Saura

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Postal Address:

31st Ave. between 158 and 190, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lopez.saura@cigb.edu.cu

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:

Dr. Pedro

Middle Name:

Antonio

Last Name:

López Saura

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Postal Address:

31st Ave. between 158 and 190, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lopez.saura@cigb.edu.cu

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:

RPCEC00000107

Date of Registration in Primary Registry:

2011-05-03

Record Verification Date:

2011-04-21 20:00

Link to the spanish version:

Click here

Versión para impresión

Ensayos Registrados

Proceso de Registro

EGFpeeling I

Acerca del RPCEC

Recursos útiles