EGFpeeling I

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000107
• Date of registration: 03/05/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: EGFpeeling I
• Scientific title: “Human Recombinant Epidermal Growth Factor to accelerate the healing after chemical peels”.
• Date of first enrolment: 30/07/2008
• Target sample size: 30
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000107-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: Dr. Pedro López Saura
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

• Name: Dr. Pedro López Saura
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Key inclusion & exclusion criteria

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.

Age minimum: 20 years
Age maximum: N/A (No limit)
Gender: Both

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.

Primary Outcome(s)

Time to healing, 1 month after treatment.

Secondary Outcome(s)

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.

Secondary ID(s)

IG/FCG/PQ/0701

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable