Atopic DermatitisPhase 3NCT03107611
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
A Phase 3 study testing Pimecrolimus Cream, 1% in people with Atopic Dermatitis, run by Mylan Inc. at 27 sites in 3 countries.
Trial summary
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis. To establish superiority of each active treatment over the placebo. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus Cream, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 654 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 29 Feb 2016to 15 May 2017
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-immuno compromised male or female aged 8 years and older
- Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
- Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
- A diagnosis of AD for at least 3 months
- An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
- Affected area of AD involvement at least 5% body surface area (BSA)
- Treated with a bland emollient for at least 7 days
Who cannot join
- Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
- Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
- Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
- History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
- 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
- Concurrent disease or treatment likely to interfere with the study treatment or evaluations
- Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
- Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
United States25 sites
Research Facility 29
Albuquerque, New Mexico, 87106
Research Facility 20
Austin, Texas, 78759
Research Facility 23
Boise, Idaho, 83704
Research Facility 6
Boynton Beach, Florida, 33437
Research Facility 24
Charlotte, North Carolina, 28277
Research Facility 16
College Station, Texas, 77845
Research Facility 4
Coral Gables, Florida, 33146
Research Facility 2
High Point, North Carolina, 27262
Research Facility 18
Johnston, Rhode Island, 02919
Research Facility 32
Louisville, Kentucky, 40241
Research Facility 5
Miami, Florida, 33144
Research Facility 10
Miami, Florida, 33175
Research Facility 1
Miami Lakes, Florida, 33014
Research Facility 9
Miramar, Florida, 33027
Research Facility 13
New Orleans, Louisiana, 70115
Research Facility 19
Omaha, Nebraska, 68114
Research Facility 28
Overland Park, Kansas, 66215
Research Facility 31
Pflugerville, Texas, 78660
Resarch Facility 8
Philadelphia, Pennsylvania, 19103
Research Facility 15
Richmond, Virginia, 23220
Research Facility 7
Saint Joseph, Missouri, 64506
Research Facility 26
Spokane, Washington, 99202
Research Facility 17
Sugar Land, Texas, 77479
Research Facility 33
Sweetwater, Florida, 33172
Research Facility 22
West Jordan, Utah, 84088
About this study
Official title: A Randomized, Prospective, Multicenter, Double Blind, Parallel Assignment, Placebo Controlled Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® (Pimecrolimus) Cream, 1% in Patients With Mild to Moderate Atopic Dermatitis
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
To establish superiority of each active treatment over the placebo.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus Cream, 1%, Placebo Cream
- 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
Placebo CreamDrug
Pimecrolimus Cream, 1%Drug
Also called Elidel (pimecrolimus) Cream, 1%
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Receives: Drug: Pimecrolimus Cream, 1% |
| Reference Standard | Active comparator | Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Receives: Drug: Pimecrolimus Cream, 1% |
| Placebo | Placebo comparator | Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days Receives: Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Measured: Day 15
Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Measured: Day 15
Secondary outcomes (2)
Change in Severity of Four Individual Signs and Symptoms
Erythema, induration/papulation, lichenification and pruritus
Measured: Day 15
Evaluation of Application Site Reactions
Dryness, burning/stinging, erosion, edema, and pain
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 posted11 Apr 2017
- Study start29 Feb 2016
- Primary completion15 May 2017
- Study completion15 May 2017
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
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DPT Laboratories, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107611
- Sponsor's protocol ID
- CD-14-875
- Status last verified
- Mar 2022
- First submitted
- 5 Apr 2017
- Last updated
- 7 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Multicenter, Double Blind, Parallel Assignment, Placebo Controlled Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® (Pimecrolimus) Cream, 1% in Patients With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03107611
- Acronym / sponsor ID
- CD-14-875
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- DPT Laboratories, Ltd.
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Posted 17 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
To establish superiority of each active treatment over the placebo.
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 |
|---|---|---|
| Test | Experimental | Drug: Pimecrolimus Cream, 1%Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days |
| Reference Standard | Active comparator | Drug: Pimecrolimus Cream, 1%Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days |
| Placebo | Placebo comparator | Drug: Placebo CreamPlacebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Non-immuno compromised male or female aged 8 years and older
- Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
- Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
- A diagnosis of AD for at least 3 months
- An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
Key exclusion criteria (8 listed)
- Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
- Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
- Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
- History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
- 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% | Drug | Test |
| Placebo Cream | Drug | Placebo |
| Pimecrolimus Cream, 1%Also: Elidel (pimecrolimus) Cream, 1% | Drug | Reference Standard |
Primary outcome
Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
Time frame: Day 15
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
Time frame: Day 15
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
2 secondary outcomes
Change in Severity of Four Individual Signs and Symptoms
Time frame: Day 15
Evaluation of Application Site Reactions
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pimecrolimus Cream, 1% in people with Atopic Dermatitis, run by Mylan Inc. at 27 sites in 3 countries.
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 7 inclusion and 8 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 7 Mar 2022. 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, Dominican Republic, Honduras. 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 17 Mar 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?
Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) (time frame: Day 15). The study lists 2 primary outcomes in all. 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 7 Mar 2022.