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

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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