Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis

NCT ID: NCT02791308

Last Updated: 2020-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 587 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-07-31

Brief Summary

The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.

Detailed Description

Pimecrolimus cream, 1% is a calcineurin inhibitor immunosuppressant. Pimecrolimus inhibits T cell activation by blocking the transcription of early cytokines. Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. This study is being conducted to evaluate the clinical bioequivalence of sponsor's formulation of Pimecrolimus Cream, 1%, the Test product, and Elidel Cream, 1%, the Reference product. A vehicle control arm is included to demonstrate that the Test and Reference products are active and to establish that the study is sufficiently sensitive to detect differences between products.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pimecrolimus Cream, 1%

Pimecrolimus Cream, 1% (Actavis)

Group Type: EXPERIMENTAL

Pimecrolimus Cream, 1%

Intervention Type: DRUG

Elidel Cream, 1%

Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)

Group Type: ACTIVE_COMPARATOR

Pimecrolimus Cream 1% (Valeant)

Intervention Type: DRUG

Vehicle Cream

Cream vehicle of the test product (Actavis)

Group Type: PLACEBO_COMPARATOR

Vehicle cream

Intervention Type: DRUG

Interventions

Pimecrolimus Cream 1% (Valeant)

Intervention Type: DRUG

Vehicle cream

Intervention Type: DRUG

Pimecrolimus Cream, 1%

Intervention Type: DRUG

Other Intervention Names

Elidel® (pimecrolimus) Cream, 1% (Valeant); Vehicle of test product (Actavis); Pimecrolimus Cream, 1% (Actavis)

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide written informed consent/assent for the study.
• Non-immunocompromised male or female aged 12 years or older.
• A clinical diagnosis of mild to moderate atopic dermatitis that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or subjects for whom the use of those other treatments is deemed inadvisable.
• A diagnosis of atopic dermatitis for at least 3 months.
• A baseline Investigator's Global Assessment (IGA) of disease severity of mild or moderate (score of 2 or 3).
• An affected area of atopic dermatitis involvement of at least 5% of the body surface area (BSA) at Visit 2/Day 1 (Baseline), as defined by the criteria of Hanifin and Rajka (1980).
• Treatment with a bland emollient for at least 7 days prior to Visit 2/Day 1 (Baseline).
• Agree to adhere to protocol-specified requirements and concomitant therapy restrictions.
• Willing to avoid constant sun exposure and the use of tanning booths or other UV light sources during participation in the study.
• In general good health, non-immunocompromised, and free from any clinically significant disease, other than atopic dermatitis, that might interfere with the study evaluations.
• Willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required study visits, comply with therapy prohibitions, and complete the study.
• Female subjects of childbearing potential (excluding women who are surgically sterilized [hysterectomy, bilateral tubal ligation, or bilateral ovariectomy] or have been postmenopausal for at least 1 year) must have a negative urine pregnancy test and must be willing to use a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), Essure® permanent birth control, and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to Visit 1.

Exclusion Criteria

• Females who were pregnant, breastfeeding, intending to become pregnant during the study, or who did not agree to use an acceptable form of birth control during the study.
• Active cutaneous bacterial or viral infection in any proposed treatment area at Visit 2/Baseline (e.g., clinically infected atopic dermatitis).
• Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Visit 2/Baseline that would interfere with the study evaluations.
• History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
• 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.
• Use of any treatment listed in Table 9.1 more recently than the indicated washout period prior to Visit 2/Baseline.
• Need or intent to continue to use any treatment listed in Table 9.1 during the current study.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beth Landis

Role: STUDY_DIRECTOR

Senior Clinical Project Manager

Locations

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Clinical Research Center of Alabama

Birmingham, Alabama, United States

Agave Clinical Research, LLC

Mesa, Arizona, United States

Omni Dermatology/Physicians Research Group, LLC

Phoenix, Arizona, United States

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, United States

MD Studies, Inc.

Fountain Valley, California, United States

Alliance Research Centers

Laguna Hills, California, United States

Medical Center for Clinical Research

San Diego, California, United States

Skin Surgery Medical Group, Inc.

San Diego, California, United States

Horizons Clinical Research Ctr., LLC

Denver, Colorado, United States

Immunoe International Research Centers

Thornton, Colorado, United States

Dermatology of Boca

Boca Raton, Florida, United States

Olympian Clinical Research

Clearwater, Florida, United States

International Dermatology Research, Inc.

Miami, Florida, United States

Radiant Research, Inc.

Pinellas Park, Florida, United States

International Clinical Research- US, LLC

Sanford, Florida, United States

MOORE Clinical Research, Inc.

Tampa, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

Kansas City Dermatology PA

Overland Park, Kansas, United States

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

Dermatology Specialists Research

Louisville, Kentucky, United States

Callender Center for Clinical Research, LLC

Glenn Dale, Maryland, United States

David Fivenson, MD, PLC

Ann Arbor, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Quality Clinical Research Inc.

Omaha, Nebraska, United States

Karl G. Heine, MD Dermatology

Henderson, Nevada, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Pinkas E. Lebovits, MD, PC

New York, New York, United States

Piedmont Plastic Surgery and Dermatology

Charlotte, North Carolina, United States

Dermatology Consulting Services

High Point, North Carolina, United States

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Cyn3rgy Research

Gresham, Oregon, United States

Baker Allergy, Asthma and Dermatology Research Center, LLC

Portland, Oregon, United States

Asthma & Allergy Research Associates

Upland, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Greenville Dermatology

Greenville, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

ClinSearch, LLC

Chattanooga, Tennessee, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

J&S Studies, Inc.

College Station, Texas, United States

Suzanne Bruce and Associates, P.A./The Center for Skin Research

Houston, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Suzanne Bruce and Associates, P.A., The Center for Skin Research

Katy, Texas, United States

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Pflugerville Dermatology Clinical Research Center, Inc.

Pflugerville, Texas, United States

ACRC Trials

Plano, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Intermountain Clinical Research

Draper, Utah, United States

The Education and Research Foundation, Inc.

Lynchburg, Virginia, United States

National Clinical Research-Richmond, Inc.

Richmond, Virginia, United States

Dermatology Associates

Seattle, Washington, United States

Eastern Washington Dermatology

Walla Walla, Washington, United States

Countries

United States

Other Identifiers

SYM 2014-03

Identifier Type: -

Identifier Source: org_study_id