Atopic DermatitisPhase 3NCT02896101
Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis
A Phase 3 study testing Pimecrolimus Cream, 1% and Elidel® (pimecrolimus) Cream in people with Atopic Dermatitis, run by Glenmark Pharmaceuticals Ltd. India at 27 sites in United States.
Trial summary
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus Cream, 1% and Elidel® (pimecrolimus) Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 755 participants
- Where
- 27 sitesUnited States
- Study dates
- Aug 2016to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating female subjects 12 years of age and older.
- Non-immunocompromised, with a clinical diagnosis of mild to moderate AD that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable.
- Confirmed diagnosis of AD for at least 3 months using the diagnostic features as described by Hanifin and Rajka.
- IGA score of 2 (mild) or 3 (moderate) and ≥ 5% BSA affected at baseline.
Who cannot join
- Active cutaneous bacterial, viral or fungal infection in any treatment area at baseline (e.g., clinically infected AD).
- Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline and history or presence of skin conditions that would interfere with evaluations.
- History or presence of Netherton's Syndrome, immunological deficiencies or diseases, organ transplant, HIV, diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant severe renal insufficiency or severe hepatic disorders.
- Use within one month before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) psoralen plus ultraviolet A therapy (PUVA), 4) tanning booths, 5) non-prescription ultraviolet (UV) light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10) pimecrolimus.
- Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids.
- Use within 7 days before baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Investigational Site 20
Anaheim, California
Investigational Site 1
Arlington Heights, Illinois
Investigational Site 15
Cincinnati, Ohio
Investigational Site 17
Doral, Florida
Investigational Site 27
East Windsor, New Jersey
Investigational Site 13
Fremont, California
Investigational Site 9
Hialeah, Florida
Investigational Site 5
High Point, North Carolina
Investigational Site 4
Hot Springs, Arkansas
Investigational Site 21
Lake Charles, Louisiana
Investigational Site 22
Little Rock, Arkansas
Investigational Site 16
Miami, Florida
Investigational Site 18
Miami, Florida
Investigational Site 19
Miami, Florida
Investigational Site 25
Miami, Florida
Investigational Site 8
Miami, Florida
Investigational Site 6
Nashville, Tennessee
Investigational Site 26
Norco, California
Investigational Site 12
North Miami Beach, Florida
Investigational Site 3
Ormond Beach, Florida
Investigational Site 23
Raleigh, North Carolina
Investigational Site 11
Saint Joseph, Missouri
Investigational Site 2
Silver Spring, Maryland
Investigational Site 7
South Miami, Florida
Investigational Site 10
Tampa, Florida
Investigational Site 24
Tampa, Florida
Investigational Site 14
West Palm Beach, Florida
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (Pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus Cream, 1%, Elidel® (pimecrolimus) Cream, Placebo of Pimecrolimus Cream, 1%
- Keywords
- Mild to moderate
- 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%Drug
Elidel® (pimecrolimus) CreamDrug
Placebo of Pimecrolimus Cream, 1%Drug
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus Cream, 1% | Experimental | Pimecrolimus Cream, 1 % (Glenmark Pharmaceuticals Ltd) topical application Receives: Drug: Pimecrolimus Cream, 1% |
| Elidel® | Active comparator | Elidel® (Valeant Pharmaceuticals North America LLC) topical application Receives: Drug: Elidel® (pimecrolimus) Cream |
| Placebo | Placebo comparator | Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application Receives: Drug: Placebo of Pimecrolimus Cream, 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3).
Measured: Day 15
Secondary outcomes (1)
Change in severity score from baseline to Visit 3 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Nikhil Sawant, Study director, Glenmark Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896101
- Sponsor's protocol ID
- GLK-1601
- Status last verified
- Jul 2019
- First submitted
- 6 Sep 2016
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (Pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).
- ClinicalTrials.gov ID
- NCT02896101
- Acronym / sponsor ID
- GLK-1601
- Conditions
- Atopic Dermatitis
- Keywords
- Mild to moderate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).
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 % (Glenmark Pharmaceuticals Ltd) topical application |
| Elidel® | Active comparator | Drug: Elidel® (pimecrolimus) CreamElidel® (Valeant Pharmaceuticals North America LLC) topical application |
| Placebo | Placebo comparator | Drug: Placebo of Pimecrolimus Cream, 1%Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant, non-lactating female subjects 12 years of age and older.
- Non-immunocompromised, with a clinical diagnosis of mild to moderate AD that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable.
- Confirmed diagnosis of AD for at least 3 months using the diagnostic features as described by Hanifin and Rajka.
- IGA score of 2 (mild) or 3 (moderate) and ≥ 5% BSA affected at baseline.
Key exclusion criteria (6 listed)
- Active cutaneous bacterial, viral or fungal infection in any treatment area at baseline (e.g., clinically infected AD).
- Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline and history or presence of skin conditions that would interfere with evaluations.
- History or presence of Netherton's Syndrome, immunological deficiencies or diseases, organ transplant, HIV, diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant severe renal insufficiency or severe hepatic disorders.
- Use within one month before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) psoralen plus ultraviolet A therapy (PUVA), 4) tanning booths, 5) non-prescription ultraviolet (UV) light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10) pimecrolimus.
- Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids.
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% | Drug | Pimecrolimus Cream, 1% |
| Elidel® (pimecrolimus) Cream | Drug | Elidel® |
| Placebo of Pimecrolimus Cream, 1% | Drug | Placebo |
Primary outcome
The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3).
Time frame: Day 15
1 secondary outcome
Change in severity score from baseline to Visit 3 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).
Time frame: Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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.
Dr. Nikhil Sawant study director
Glenmark Pharmaceuticals Ltd.
27 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% and Elidel® (pimecrolimus) Cream in people with Atopic Dermatitis, run by Glenmark Pharmaceuticals Ltd. India at 27 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 4 inclusion and 6 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3). (time frame: Day 15). 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 31 Jul 2019.