Atopic DermatitisPhase 3NCT03297502
Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis
A Phase 3 study testing pimecrolimus cream 1% and Elidel (pimecrolimus) cream 1% in people with Atopic Dermatitis, run by Par Pharmaceutical, Inc..
Trial summary
A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus Cream, 1%). 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 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 582 participants
- Where
- No sites listed yet
- Study dates
- Jun 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
- 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). (See Section 9.6.10 for the scale.)
- 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).
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- 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.
Who cannot join
- Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do 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.
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- Need or intent to continue to use any treatment listed in Table 9.1 during the current study.
- Table 9.1 Medications, Supplements, and Other Substances Prohibited for Study Entry Prohibited Medications, Supplements, and Other Substances Washout Period Prior to Randomization Visit 2/Baseline
- Systemic corticosteroids (oral and injectable [intravenous and intramuscular]) (Intranasal and Inhalational steroids are allowed if use is kept constant during the study)
- UVA/UVB therapy
- PUVA (psoralen plus ultraviolet A) therapy
- Tanning booths
- Nonprescription UV light sources
- Immunomodulators or immunosuppressive therapies
- Interferon
- Cytotoxic drugs (e.g., methotrexate, cyclophosphamide, azathioprine)
- Oral retinoids
- Systemic anti-fungals
- Tacrolimus
- Pimecrolimus 30 days (1 month)
- Systemic antibiotics
- Topical calcipotriene or other topical vitamin D preparations
- Topical retinoids 14 days (2 weeks)
- Topical and oral antihistamines
- Topical antibiotics
- Topical corticosteroids
- Topical antifungals
- Other topical drug products 7 days (1 week)
- Any topical product (e.g., sunscreens, lotions, creams) in areas to be treated except for bland emollient (moisturizer)
- Grapefruit or grapefruit juice which is considered a CYP3A inhibitor 24 hours
- Current use of calcium channel blockers (e.g, amlodipine, nifedipine, verapamil, diltiazem, felodipine, isradipine, nisoldipine, etc) and/or cimetidine (e.g., Tagamet) which are CPY3A inhibitors.
- Known allergy or hypersensitivity to pimecrolimus or any other component of the Test or Reference product.
- Unwilling to minimize or avoid natural and artificial sunlight exposure during treatment.
- Consumption of excessive alcohol, abuse of drugs, or a condition that could compromise the subject's ability to comply with study requirements.
- Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
- Use of any investigational drug or investigational device within 30 days prior to Visit 2/Baseline.
- Previous participation in this study.
- Employees of the research center or investigator.
- Family members of employees of the research center or investigator.
- Family members living in the same household participating at the same time.
- Table 9.2 Medications (Prescription and Over-the-Counter), Supplements, and Other Substances Prohibited During the Study Prohibited Medications, Supplements, and Other Substances Treatment for atopic dermatitis other than assigned study medication or bland emollient.
- Topical or systemic (oral and injectable) corticosteroid (Intranasal and inhalational steroids are allowed if kept constant during the study) Topical or systemic antibiotic Topical or systemic antifungal Topical or oral antihistamine (e.g., diphenhydramine, hydroxyzine) Immunosuppressive drugs Immunomodulator (e.g., tacrolimus) Calcipotriene or other topical vitamin D preparations Topical or oral retinoids Interferon Cyclosporine Methotrexate Azathioprine CPY3A inhibitor (e.g., erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, cimetidine, grapefruit or grapefruit juice) Topical product other than assigned study medication or bland emollient (e.g., sunscreen, new brand of cosmetic or cleanser, cream, lotion, ointment, or powder) applied on or near the treatment area(s) Phototherapy (e.g., PUVA, UVA or UVB therapy)
About this study
Official title: Multicenter Study of the Safety and Bioequivalence of Par's Pimecrolimus Cream, 1% and RLD Elidel® (Pimecrolimus Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in Treatment of Mild to Moderate Atopic Dermatitis
A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus Cream, 1%). The study compares both active treatments to a placebo control in the treatment of mild to moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- pimecrolimus cream 1%, Elidel (pimecrolimus) cream 1%, placebo
- 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) cream 1%Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus cream, 1% | Experimental | Not described Receives: Drug: pimecrolimus cream 1% |
| Elidel (pimecrolimus) cream 1% | Active comparator | Not described Receives: Drug: Elidel (pimecrolimus) cream 1% |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with treatment success in each treatment group
Treatment success is defined as an Investigator's Global Assessment (IGA) Rating of "clear" or "almost clear" ( i.e., a score of 0 or 1 on a scale of 0 [clear] through 4. IGA Scale: 0 = Clear (minor discoloration, no erythema, induration, population, oozing/crusting. 1= Almost Clear (trace, faint erythema, almost no induration/population, no oozing/crusting. 2 = Mild (faint erythema, mild induration/population, no oozing/crusting. 3 = Moderate (Pink-red erythema, moderate induration/population, some oozing/crusting. 4 = Severe (Deep/bright erythema, severe induration/population, with oozing/crusting.
Measured: Day 15
Secondary outcomes (4)
Change from baseline in severity (erythema)
Change from baseline in severity in clinical signs and symptoms of erythema is assessed.
0 = None: No erythema present
- = Mild: Slight erythema, very light-pink
- = Moderate: Dull red, clearly distinguishable
- = Severe: Deep/dark red
Measured: Baseline, Day 15
Change from baseline in severity (induration/population)
Change from baseline in severity in clinical signs and symptoms of induration/papulation is assessed.
0 = None: No elevation
- = Mild: Slightly perceptible elevation
- = Moderate: Clearly perceptible elevation
- = Severe: Marked and extensive elevation
Measured: Baseline, Day 15
Change from baseline in severity (lichenification)
Change from baseline in severity in clinical signs and symptoms of lichenification is assessed.
0 = None: No lichenification
- = Mild: Slight thickening of the skin discernible only by touch and with skin markings minimally exaggerated
- = Moderate: Definite thickening of the skin with skin markings exaggerated so that they form a visible criss-cross pattern
- = Severe: Thickened indurated skin with skin markings visibly portraying an exaggerated criss-cross pattern
Measured: Baseline, Day 15
Change from baseline in severity (pruritis)
Change from baseline in severity in clinical signs and symptoms of puritus is assessed.
0 = None: No itching
- = Mild: Occasional, slight itching/scratching
- = Moderate: Constant or intermittent itching/scratching/discomfort that is not disturbing sleep
- = Severe: Bothersome itching/scratching/discomfort that is disturbing sleep
Measured: Baseline, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study startJun 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
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Davis, MD, RPh, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297502
- Sponsor's protocol ID
- SYM 2016-01
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of the Safety and Bioequivalence of Par's Pimecrolimus Cream, 1% and RLD Elidel® (Pimecrolimus Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in Treatment of Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03297502
- Acronym / sponsor ID
- SYM 2016-01
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Sep 2017 (actual)
- 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.
A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus Cream, 1%). The study compares both active treatments to a placebo control in the treatment of mild to moderate atopic dermatitis.
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% |
| Elidel (pimecrolimus) cream 1% | Active comparator | Drug: Elidel (pimecrolimus) cream 1% |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not 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). (See Section 9.6.10 for the scale.)
Key exclusion criteria (42 listed)
- Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do 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% | Drug | Pimecrolimus cream, 1% |
| Elidel (pimecrolimus) cream 1% | Drug | Elidel (pimecrolimus) cream 1% |
| placebo | Drug | placebo |
Primary outcome
Proportion of subjects with treatment success in each treatment group
Time frame: Day 15
Treatment success is defined as an Investigator's Global Assessment (IGA) Rating of "clear" or "almost clear" ( i.e., a score of 0 or 1 on a scale of 0 [clear] through 4. IGA Scale: 0 = Clear (minor discoloration, no erythema, induration, population, oozing/crusting. 1= Almost Clear (trace, faint erythema, almost no induration/population, no oozing/crusting. 2 = Mild (faint erythema, mild induration/population, no oozing/crusting. 3 = Moderate (Pink-red erythema, moderate induration/population, some oozing/crusting. 4 = Severe (Deep/bright erythema, severe induration/population, with oozing/crusting.
4 secondary outcomes
Change from baseline in severity (erythema)
Time frame: Baseline, Day 15
Change from baseline in severity (induration/population)
Time frame: Baseline, Day 15
Change from baseline in severity (lichenification)
Time frame: Baseline, Day 15
Change from baseline in severity (pruritis)
Time frame: Baseline, 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 29 Sep 2017.
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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.
Matthew Davis, MD, RPh study director
Endo USA Inc., a Keenova Therapeutics Company
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pimecrolimus cream 1% and Elidel (pimecrolimus) cream 1% in people with Atopic Dermatitis, run by Par Pharmaceutical, Inc..
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 42 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 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of subjects with treatment success in each treatment group (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 29 Sep 2017.