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

NCT02791308 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SYM 2014-03
• Study Type: interventional
• Target: 587
• Locations: 1 country
• Sites: 53

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Treatment Success at Visit 4/Day 15

  Percentage of subjects in each treatment group with treatment success, defined as a grade of clear or almost clear (a score of 0 or 1 on the IGA) within all treatment areas at the end of treatment on Visit 4/Day 15

  15 days

Study Arms (3)

Pimecrolimus Cream, 1%

EXPERIMENTAL

Pimecrolimus Cream, 1% (Actavis)

Drug: Pimecrolimus Cream, 1%

Elidel Cream, 1%

ACTIVE COMPARATOR

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

Drug: Pimecrolimus Cream 1% (Valeant)

Vehicle Cream

PLACEBO COMPARATOR

Cream vehicle of the test product (Actavis)

Drug: Vehicle cream

Interventions

Pimecrolimus Cream 1% (Valeant) DRUG

Also known as: Elidel® (pimecrolimus) Cream, 1% (Valeant)

Elidel Cream, 1%

Vehicle cream DRUG

Also known as: Vehicle of test product (Actavis)

Vehicle Cream

Pimecrolimus Cream, 1% DRUG

Also known as: Pimecrolimus Cream, 1% (Actavis)

Pimecrolimus Cream, 1%

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (53)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Clinical Research Center of Alabama

Birmingham, Alabama, 35209, United States

Location

Agave Clinical Research, LLC

Mesa, Arizona, 85202, United States

Location

Omni Dermatology/Physicians Research Group, LLC

Phoenix, Arizona, 85018, United States

Location

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, 72758, United States

Location

MD Studies, Inc.

Fountain Valley, California, 92708, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Horizons Clinical Research Ctr., LLC

Denver, Colorado, 80220, United States

Location

Immunoe International Research Centers

Thornton, Colorado, 80233, United States

Location

Dermatology of Boca

Boca Raton, Florida, 33431, United States

Location

Olympian Clinical Research

Clearwater, Florida, 33757, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Radiant Research, Inc.

Pinellas Park, Florida, 33781, United States

Location

International Clinical Research- US, LLC

Sanford, Florida, 32771, United States

Location

MOORE Clinical Research, Inc.

Tampa, Florida, 33609, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

Kansas City Dermatology PA

Overland Park, Kansas, 66215, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40202, United States

Location

Callender Center for Clinical Research, LLC

Glenn Dale, Maryland, 20769, United States

Location

David Fivenson, MD, PLC

Ann Arbor, Michigan, 48103, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Quality Clinical Research Inc.

Omaha, Nebraska, 68114, United States

Location

Karl G. Heine, MD Dermatology

Henderson, Nevada, 89052, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Pinkas E. Lebovits, MD, PC

New York, New York, 10019, United States

Location

Piedmont Plastic Surgery and Dermatology

Charlotte, North Carolina, 28277, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Baker Allergy, Asthma and Dermatology Research Center, LLC

Portland, Oregon, 97223, United States

Location

Asthma & Allergy Research Associates

Upland, Pennsylvania, 19013, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Greenville Dermatology

Greenville, South Carolina, 29607, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

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

Houston, Texas, 77056, United States

Location

Center for Clinical Studies

Houston, Texas, 77065, United States

Location

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

Katy, Texas, 77494, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Pflugerville Dermatology Clinical Research Center, Inc.

Pflugerville, Texas, 78660, United States

Location

ACRC Trials

Plano, Texas, 75024, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Intermountain Clinical Research

Draper, Utah, 84020, United States

Location

The Education and Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

National Clinical Research-Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

Dermatology Associates

Seattle, Washington, 98101, United States

Location

Eastern Washington Dermatology

Walla Walla, Washington, 99362, United States

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: Senior Director, CE Studies
• Organization: Teva Pharmaceuticals Inc. USA

USMedinfo@tevapharm.com

1-888-483-8279

Study Officials

• Beth Landis

  Senior Clinical Project Manager

  STUDY DIRECTOR

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: June 1, 2016
• First Posted: June 6, 2016
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 29, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)