NCT00810862

Brief Summary

Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
Last Updated

December 18, 2008

Status Verified

December 1, 2008

Enrollment Period

1.6 years

First QC Date

December 17, 2008

Last Update Submit

December 17, 2008

Conditions

Atopic Dermatitis

Keywords

African American children

Outcome Measures

Primary Outcomes (1)

  • Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis

    at baseline, one week and three weeks following treatment initiation

Secondary Outcomes (2)

  • modified IGA score

    at baseline, one week and three weeks following initiation of therapy

  • hypopigmentation scale score

    baseline, one and three weeks following initiation of treatment

Study Arms (2)

Pimecrolimus

EXPERIMENTAL

Pimecrolimus 1% cream

Drug: pimecrolimus active cream

2

PLACEBO COMPARATOR

Placebo cream over affected study area

Other: placebo base cream

Interventions

pimecrolimus active creamDRUG

Pimecrolimus 1% cream apply to affected study area twice daily for 21 days

Also known as: Elidel 1% cream Novartis Pharmaceuticals
Pimecrolimus
placebo base creamOTHER

apply to affected study area twice daily for 21 days

Also known as: Elidel base cream without active agent, by Novartis Pharmaceuticals
2

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • African American children aged 2 to 17 years
  • mild to moderate atopic dermatitis

You may not qualify if:

  • m-EASI less than 3 at baseline
  • allergy to Elidel or components
  • use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study.
  • previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment.
  • active skin infections.
  • immunocompromised patients.
  • previous history of skin cancer or lymphoma
  • any hypopigmentation in study areas
  • pregnant or breastfeeding
  • participation in another investigational trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

November 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 18, 2008

Record last verified: 2008-12