A Randomized, Prospective, Multicenter, Double Blind, Parallel Assignment, Placebo Controlled Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® (Pimecrolimus) Cream, 1% in Patients With Mild to Moderate Atopic Dermatitis
Overview
- Phase
- Phase 3
- Intervention
- Pimecrolimus Cream, 1%
- Conditions
- Atopic Dermatitis
- Sponsor
- Mylan Inc.
- Enrollment
- 654
- Locations
- 27
- Primary Endpoint
- Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
To establish superiority of each active treatment over the placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Non-immuno compromised male or female aged 8 years and older
- •Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
- •Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
- •A diagnosis of AD for at least 3 months
- •An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
- •Affected area of AD involvement at least 5% body surface area (BSA)
- •Treated with a bland emollient for at least 7 days
Exclusion Criteria
- •Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
- •Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
- •Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
- •History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
- •History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders
- •Concurrent disease or treatment likely to interfere with the study treatment or evaluations
- •Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
- •Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
Arms & Interventions
Test
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Intervention: Pimecrolimus Cream, 1%
Reference Standard
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Intervention: Pimecrolimus Cream, 1%
Placebo
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Intervention: Placebo Cream
Outcomes
Primary Outcomes
Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
Time Frame: Day 15
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
Time Frame: Day 15
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Secondary Outcomes
- Change in Severity of Four Individual Signs and Symptoms(Day 15)
- Evaluation of Application Site Reactions(Day 15)