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

Double-Blind Randomized Vehicle Controlled Study Evaluating Safety and Bioequivalence of Generic Pimecrolimus Cream 1% and Elidel® Comparing Both Active Treatments to a Vehicle Control in Treatment of Mild to Moderate Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Pimecrolimus Cream, 1%; Drug: Pimecrolimus Cream 1% (Valeant); Drug: Vehicle cream

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.

• Study Type: Interventional
• Enrollment (Actual): 587
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Agave Clinical Research, LLC
    • Phoenix, Arizona, United States, 85018
      • Omni Dermatology/Physicians Research Group, LLC
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center, PLLC
  • California
    • Fountain Valley, California, United States, 92708
      • MD Studies, Inc.
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group, Inc.
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Ctr., LLC
    • Thornton, Colorado, United States, 80233
      • IMMUNOe International Research Centers
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Dermatology of Boca
    • Clearwater, Florida, United States, 33757
      • Olympian Clinical Research
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research, Inc.
    • Sanford, Florida, United States, 32771
      • International Clinical Research- US, LLC
    • Tampa, Florida, United States, 33609
      • MOORE Clinical Research, Inc.
    • Tampa, Florida, United States, 33609
      • Olympian Clinical Research
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Kansas City Dermatology PA
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric/Adult Research
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Callender Center for Clinical Research, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD, PLC
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research Inc.
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Karl G. Heine, MD Dermatology
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • New York, New York, United States, 10019
      • Pinkas E. Lebovits, MD, PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Piedmont Plastic Surgery and Dermatology
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research
    • Portland, Oregon, United States, 97223
      • Baker Allergy, Asthma and Dermatology Research Center, LLC
  • Pennsylvania
    • Upland, Pennsylvania, United States, 19013
      • Asthma & Allergy Research Associates
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Greenville Dermatology
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc.
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, P.A./The Center for Skin Research
    • Houston, Texas, United States, 77065
      • Center for Clinical Studies
    • Katy, Texas, United States, 77494
      • Suzanne Bruce and Associates, P.A., The Center for Skin Research
    • Lake Jackson, Texas, United States, 77566
      • R/D Clinical Research, Inc.
    • Pflugerville, Texas, United States, 78660
      • Pflugerville Dermatology Clinical Research Center, Inc.
    • Plano, Texas, United States, 75024
      • ACRC Trials
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
  • Utah
    • Draper, Utah, United States, 84020
      • Intermountain Clinical Research
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education and Research Foundation, Inc.
    • Richmond, Virginia, United States, 23294
      • National Clinical Research-Richmond, Inc.
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates
    • Walla Walla, Washington, United States, 99362
      • Eastern Washington Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pimecrolimus Cream, 1%; Pimecrolimus Cream, 1% (Actavis)	Drug: Pimecrolimus Cream, 1%; Other Names: Pimecrolimus Cream, 1% (Actavis)
Active Comparator: Elidel Cream, 1%; Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)	Drug: Pimecrolimus Cream 1% (Valeant); Other Names: Elidel® (pimecrolimus) Cream, 1% (Valeant)
Placebo Comparator: Vehicle Cream; Cream vehicle of the test product (Actavis)	Drug: Vehicle cream; Other Names: Vehicle of test product (Actavis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Actavis Inc.
• Investigators: Study Director: Beth Landis, Senior Clinical Project Manager

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimate): June 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Calcineurin Inhibitors; Tacrolimus; Pimecrolimus
• Other Study ID Numbers: SYM 2014-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No