Efficacy Study of Dialyzed Leukocytes Extracts to Treat Paediatric Moderate Atopic Dermatitis

National Polytechnic Institute, Mexico

Status and phase: Completed; Phase 2

Conditions: Childhood Atopic Dermatitis

Treatments: Biological: Conventional treatment plus placebo; Biological: Conventional treatment plus DLE

Study type: Interventional

Funder types: Other

Identifiers

NCT01902836

IC-11-06

Details and patient eligibility

About

Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients treated only with conventional treatment.

Enrollment: 58 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Atopic dermatitis diagnosis by Hanifin and Rajka classification
• Dermatitis severity: Moderate, according with SCORAD index.
• Patients without treatment of topical steroids or immunosuppressants in the last 3 weeks.
• Patients with "informed consent form" signed by both parents, or advisor.
• Patients 7 years old or older whom have signed the assent form

Exclusion criteria

• Patient who were treated with topical, or systemic steroids and/or immunosuppressants and they cannot discontinue their treatment.
• Patients who lived far from the hospital and they could not go to the visits.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups, including a placebo group

Conventional Treatment plus DLE

Experimental group

Description:

Conventional treatment plus DLE Conventional treatment: oral Cetirizine 0.25mg/kg, every day, for 4 weeks; chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks; and topical Methylprednisolone 0.1% over affected skin area, every 12h for 10 days, then every 24h for 10 days, then every 48h for 10 days and suspend; Dialyzed Leukocyte Extracts as Adjuvant Treatment: oral DLE (Transferon) (2mg/5mL), then every day for 5 days, and then every 72hrs to complete one month.

Treatment:

Biological: Conventional treatment plus DLE

Conventional treatment plus placebo

Placebo Comparator group

Description:

Conventional treatment plus placebo: oral Cetirizine 0.25mg/kg, every day, for 4 weeks; chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks; and topical Methylprednisolone 0.1% over affected skin area, every 12h for 10 days, then every 24h for 10 days, then every 48h for 10 days and suspend; plus oral placebo, every day for 5 days, then every 72hrs to complete one month.

Treatment:

Biological: Conventional treatment plus placebo