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Atopic DermatitisPhase 3NCT02791308

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

A Phase 3 study testing Pimecrolimus Cream 1% (Valeant) and Pimecrolimus Cream, 1% in people with Atopic Dermatitis, run by Actavis Inc. at 53 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
Pimecrolimus Cream 1% (Valeant) and Pimecrolimus Cream, 1%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
587 participants
Where
53 sitesUnited States
Study dates
Feb 2015to Jul 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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).
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • Academic Dermatology Associates

    Albuquerque, New Mexico, 87106

  • David Fivenson, MD, PLC

    Ann Arbor, Michigan, 48103

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Kentucky Pediatric/Adult Research

    Bardstown, Kentucky, 40004

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209

  • Dermatology of Boca

    Boca Raton, Florida, 33431

  • Piedmont Plastic Surgery and Dermatology

    Charlotte, North Carolina, 28277

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Olympian Clinical Research

    Clearwater, Florida, 33757

  • J&S Studies, Inc.

    College Station, Texas, 77845

  • Horizons Clinical Research Ctr., LLC

    Denver, Colorado, 80220

  • Intermountain Clinical Research

    Draper, Utah, 84020

  • MD Studies, Inc.

    Fountain Valley, California, 92708

  • Minnesota Clinical Study Center

    Fridley, Minnesota, 55432

  • Callender Center for Clinical Research, LLC

    Glenn Dale, Maryland, 20769

  • Greenville Dermatology

    Greenville, South Carolina, 29607

  • Cyn3rgy Research

    Gresham, Oregon, 97030

  • Karl G. Heine, MD Dermatology

    Henderson, Nevada, 89052

  • Dermatology Consulting Services

    High Point, North Carolina, 27262

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

    Houston, Texas, 77056

  • Center for Clinical Studies

    Houston, Texas, 77065

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

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

    Katy, Texas, 77494

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas, 77566

  • Dermatology Specialists Research

    Louisville, Kentucky, 40202

  • The Education and Research Foundation, Inc.

    Lynchburg, Virginia, 24501

  • Agave Clinical Research, LLC

    Mesa, Arizona, 85202

  • International Dermatology Research, Inc.

    Miami, Florida, 33144

  • Tennessee Clinical Research Center

    Nashville, Tennessee, 37215

  • Pinkas E. Lebovits, MD, PC

    New York, New York, 10019

  • Quality Clinical Research Inc.

    Omaha, Nebraska, 68114

  • Kansas City Dermatology PA

    Overland Park, Kansas, 66215

  • Pflugerville Dermatology Clinical Research Center, Inc.

    Pflugerville, Texas, 78660

  • Omni Dermatology/Physicians Research Group, LLC

    Phoenix, Arizona, 85018

  • Radiant Research, Inc.

    Pinellas Park, Florida, 33781

  • ACRC Trials

    Plano, Texas, 75024

  • Baker Allergy, Asthma and Dermatology Research Center, LLC

    Portland, Oregon, 97223

  • National Clinical Research-Richmond, Inc.

    Richmond, Virginia, 23294

  • Northwest Arkansas Clinical Trials Center, PLLC

    Rogers, Arkansas, 72758

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Skin Surgery Medical Group, Inc.

    San Diego, California, 92117

  • International Clinical Research- US, LLC

    Sanford, Florida, 32771

  • Dermatology Associates

    Seattle, Washington, 98101

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • MOORE Clinical Research, Inc.

    Tampa, Florida, 33609

  • Olympian Clinical Research

    Tampa, Florida, 33609

  • Immunoe International Research Centers

    Thornton, Colorado, 80233

  • Asthma & Allergy Research Associates

    Upland, Pennsylvania, 19013

  • Eastern Washington Dermatology

    Walla Walla, Washington, 99362

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Pimecrolimus Cream 1% (Valeant), Vehicle cream, Pimecrolimus Cream, 1%
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pimecrolimus Cream 1% (Valeant)Drug

    Also called Elidel® (pimecrolimus) Cream, 1% (Valeant)

  • Vehicle creamDrug

    Also called Vehicle of test product (Actavis)

  • Pimecrolimus Cream, 1%Drug

    Also called Pimecrolimus Cream, 1% (Actavis)

Study groups in NCT02791308
Study groupRoleWhat they receive
Pimecrolimus Cream, 1%ExperimentalPimecrolimus Cream, 1% (Actavis)
Receives: Drug: Pimecrolimus Cream, 1%
Elidel Cream, 1%Active comparatorReference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)
Receives: Drug: Pimecrolimus Cream 1% (Valeant)
Vehicle CreamPlacebo comparatorCream vehicle of the test product (Actavis)
Receives: Drug: Vehicle cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2016 (estimated)
  2. Study startFeb 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
587 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02791308
Sponsor's protocol ID
SYM 2014-03
Status last verified
May 2020
First submitted
1 Jun 2016
Last updated
29 May 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimecrolimus Cream 1% (Valeant) and Pimecrolimus Cream, 1% in people with Atopic Dermatitis, run by Actavis Inc. at 53 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Treatment Success at Visit 4/Day 15 (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02791308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.

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