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

May 14, 2020 updated by: Actavis Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
587

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Treatment Success at Visit 4/Day 15
Time Frame: 15 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actavis Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Beth Landis, Senior Clinical Project Manager

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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