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

NCT03107611 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CD-14-875
• Study Type: interventional
• Target: 654
• Locations: 3 countries
• Sites: 27

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in Severity of Four Individual Signs and Symptoms

  Day 15

• Evaluation of Application Site Reactions

  Day 15

Study Arms (3)

Test

EXPERIMENTAL

Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days

Drug: Pimecrolimus Cream, 1%

Reference Standard

ACTIVE COMPARATOR

Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days

Drug: Pimecrolimus Cream, 1%

Placebo

PLACEBO COMPARATOR

Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days

Drug: Placebo Cream

Interventions

Pimecrolimus Cream, 1% DRUG

Test

Placebo Cream DRUG

Placebo

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mylan Inc.: lead
• DPT Laboratories, Ltd.: collaborator

Study Sites (27)

Research Facility 6

Boynton Beach, Florida, 33437, United States

Location

Research Facility 4

Coral Gables, Florida, 33146, United States

Location

Research Facility 5

Miami, Florida, 33144, United States

Location

Research Facility 10

Miami, Florida, 33175, United States

Location

Research Facility 1

Miami Lakes, Florida, 33014, United States

Location

Research Facility 9

Miramar, Florida, 33027, United States

Location

Research Facility 33

Sweetwater, Florida, 33172, United States

Location

Research Facility 23

Boise, Idaho, 83704, United States

Location

Research Facility 28

Overland Park, Kansas, 66215, United States

Location

Research Facility 32

Louisville, Kentucky, 40241, United States

Location

Research Facility 13

New Orleans, Louisiana, 70115, United States

Location

Research Facility 7

Saint Joseph, Missouri, 64506, United States

Location

Research Facility 19

Omaha, Nebraska, 68114, United States

Location

Research Facility 29

Albuquerque, New Mexico, 87106, United States

Location

Research Facility 24

Charlotte, North Carolina, 28277, United States

Location

Research Facility 2

High Point, North Carolina, 27262, United States

Location

Resarch Facility 8

Philadelphia, Pennsylvania, 19103, United States

Location

Research Facility 18

Johnston, Rhode Island, 02919, United States

Location

Research Facility 20

Austin, Texas, 78759, United States

Location

Research Facility 16

College Station, Texas, 77845, United States

Location

Research Facility 31

Pflugerville, Texas, 78660, United States

Location

Research Facility 17

Sugar Land, Texas, 77479, United States

Location

Research Facility 22

West Jordan, Utah, 84088, United States

Location

Research Facility 15

Richmond, Virginia, 23220, United States

Location

Research Facility 26

Spokane, Washington, 99202, United States

Location

Research Facility 11

Santo Domingo, Dominican Republic

Location

Research Facility 12

San Pedro Sula, Honduras

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Prasanna C Ganapathi, Clinical Sciences Program Lead
• Organization: Mylan Pharmaceuticals Pvt Ltd

PrasannaC.Ganapathi@mylan.in

+91 9148448200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: February 29, 2016
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: March 7, 2022
• Results First Posted: March 17, 2020

Record last verified: 2022-03

Locations

US (25); DO (1); HO (1)