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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03107611
Other study ID # CD-14-875
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 29, 2016
Est. completion date May 15, 2017

Study information

Verified date March 2022
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 654
Est. completion date May 15, 2017
Est. primary completion date May 15, 2017
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pimecrolimus Cream, 1%

Placebo Cream

Pimecrolimus Cream, 1%


Locations

Country Name City State
Dominican Republic Research Facility 11 Santo Domingo
Honduras Research Facility 12 San Pedro Sula
United States Research Facility 29 Albuquerque New Mexico
United States Research Facility 20 Austin Texas
United States Research Facility 23 Boise Idaho
United States Research Facility 6 Boynton Beach Florida
United States Research Facility 24 Charlotte North Carolina
United States Research Facility 16 College Station Texas
United States Research Facility 4 Coral Gables Florida
United States Research Facility 2 High Point North Carolina
United States Research Facility 18 Johnston Rhode Island
United States Research Facility 32 Louisville Kentucky
United States Research Facility 10 Miami Florida
United States Research Facility 5 Miami Florida
United States Research Facility 1 Miami Lakes Florida
United States Research Facility 9 Miramar Florida
United States Research Facility 13 New Orleans Louisiana
United States Research Facility 19 Omaha Nebraska
United States Research Facility 28 Overland Park Kansas
United States Research Facility 31 Pflugerville Texas
United States Resarch Facility 8 Philadelphia Pennsylvania
United States Research Facility 15 Richmond Virginia
United States Research Facility 7 Saint Joseph Missouri
United States Research Facility 26 Spokane Washington
United States Research Facility 17 Sugar Land Texas
United States Research Facility 33 Sweetwater Florida
United States Research Facility 22 West Jordan Utah

Sponsors (2)

Lead Sponsor Collaborator
Mylan Inc. DPT Laboratories, Ltd.

Countries where clinical trial is conducted

United States,  Dominican Republic,  Honduras, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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]) 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 Day 15
Primary 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]) 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 Day 15
Secondary Change in Severity of Four Individual Signs and Symptoms Erythema, induration/papulation, lichenification and pruritus Day 15
Secondary Evaluation of Application Site Reactions Dryness, burning/stinging, erosion, edema, and pain Day 15
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