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An Efficacy and Safety Study of Tacrolimus Ointment in Pediatric Participants With Atopic Dermatitis

NCT01782729 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-04-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in treating the signs and symptoms of moderate (medium level of seriousness) to severe (very serious, life threatening) atopic dermatitis (an intensely pruritic \[itching\], chronic \[lasting a long time\], inflammatory \[pain and swelling\], immunologically based skin disease with a genetic predisposition \[latent susceptibility to disease at the genetic level\]) in pediatric participants.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

Tacrolimus

Tacrolimus ointment, 0.03 percent twice a day for pediatric population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.

Sponsors & Collaborators

  • Janssen-Cilag Ltd.,Thailand

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd.,Thailand Clinical Trial · Janssen-Cilag Ltd.,Thailand

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Vietnam

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01782729 on ClinicalTrials.gov