Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107611
• Other study ID #: CD-14-875
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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