Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667160
• Other study ID #: 20-02-006
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2008
• Last updated: September 17, 2014
• Start date: December 2002
• Est. completion date: November 2003

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body surface area

• If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

• Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated

• Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters

• Patient has clinically infected Atopic Dermatitis at baseline

• Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug

• Patient has a known hypersensitivity to macrolides or any excipient of either study medication

• Patient has a chronic condition which is either not stable or not well controlled

• Patient is pregnant or breast feeding an infant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• tacrolimus ointment
topical
• pimecrolimus cream
topical

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Eczema Area and Severity Index (EASI)		6 Weeks	No
Secondary	Investigator's Global Atopic Dermatitis Assessment (IGADA)		6 Weeks	No
Secondary	Patient's evaluation of itch		6 Weeks	No
Secondary	Body surface area affected		6 Weeks	No

External Links

•   Link to Results on JAPIC - enter 140579 in the JapicCTI-RNo. field