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.
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
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.
- Conditions
- Atopic Dermatitis
- 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 group | Role | What they receive |
|---|---|---|
| Pimecrolimus Cream, 1% | Experimental | Pimecrolimus Cream, 1% (Actavis) Receives: Drug: Pimecrolimus Cream, 1% |
| Elidel Cream, 1% | Active comparator | Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC) Receives: Drug: Pimecrolimus Cream 1% (Valeant) |
| Vehicle Cream | Placebo comparator | Cream 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.
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.
- First posted6 Jun 2016 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beth Landis, Study director, Senior Clinical Project Manager
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02791308
- Acronym / sponsor ID
- SYM 2014-03
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus Cream, 1% | Experimental | Drug: Pimecrolimus Cream, 1%Pimecrolimus Cream, 1% (Actavis) |
| Elidel Cream, 1% | Active comparator | Drug: Pimecrolimus Cream 1% (Valeant)Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC) |
| Vehicle Cream | Placebo comparator | Drug: Vehicle creamCream vehicle of the test product (Actavis) |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pimecrolimus Cream 1% (Valeant)Also: Elidel® (pimecrolimus) Cream, 1% (Valeant) | Drug | Elidel Cream, 1% |
| Vehicle creamAlso: Vehicle of test product (Actavis) | Drug | Vehicle Cream |
| Pimecrolimus Cream, 1%Also: Pimecrolimus Cream, 1% (Actavis) | Drug | Pimecrolimus Cream, 1% |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Landis study director
Senior Clinical Project Manager
53 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.