San Francisco, California 94118

  • Dermatitis, Atopic


A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis


Inclusion Criteria: - Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area - Negative pregnancy test and agrees to practice effective birth control during the study Exclusion Criteria: - Skin disorder other than Atopic Dermatitis in the areas to be treated - Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters - Clinically infected Atopic Dermatitis at baseline - Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug - Known hypersensitivity to macrolides or any excipient of either study medication - Chronic condition which is either not stable or not well controlled - Pregnant or breast feeding an infant

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis

Official Title:

A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis

Overall Status:


Study Phase:

Phase 4



Minimum Age:

16 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Astellas Pharma Inc

Oversight Authority:

  • United States: Institutional Review Board
  • Canada: Canadian Institutes of Health Research

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification: S

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Use central contact
Study Director
Astellas Pharma US, Inc.

Study Dates

Start Date:October 2002
Completion Date:November 2003
Completion Type:Actual
Primary Completion Date:November 2003
Primary Completion Type:Actual
Verification Date:September 2014
Last Changed Date:September 17, 2014
First Received Date:April 23, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Body surface area affected
Time Frame:6 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient's evaluation of itch
Time Frame:6 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Investigator's Global Atopic Dermatitis Assessment (IGADA)
Time Frame:6 Weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in Eczema Area and Severity Index (EASI)
Time Frame:6 Weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:tacrolimus ointment
Arm Name:1
Other Name:Protopic
Intervention Type:Drug
Name:pimecrolimus cream
Arm Name:2
Other Name:Elidel

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Astellas Pharma Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Fleischer AB Jr, Abramovits W, Breneman D, Jaracz E; US/Canada tacrolimus ointment study group. Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis. J Dermatolog Treat. 2007;18(3):151-7.
Reference Type:Reference
Citation:Paller AS, Lebwohl M, Fleischer AB Jr, Antaya R, Langley RG, Kirsner RS, Blum RR, Rico MJ, Jaracz E, Crowe A, Linowski GJ; US/Canada Tacrolimus Ointment Study Group. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol. 2005 May;52(5):810-22.
Reference Type:Reference
Citation:Kirsner RS, Heffernan MP, Antaya R. Safety and efficacy of tacrolimus ointment versus pimecrolimus cream in the treatment of patients with atopic dermatitis previously treated with corticosteroids. Acta Derm Venereol. 2010;90(1):58-64. doi: 10.2340/00015555-0748.

Data Source:

Date Processed: March 30, 2020

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