Atopic DermatitisPhase 4NCT01177566
Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.
A Phase 4 study testing pimecrolimus and topical medical device in people with Atopic Dermatitis, run by Emer, Jason, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to assess a bilateral comparison between pimecrolimus cream 1% (Elidel®) and a medical device cream (EletoneTM) in the treatment and management of atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- pimecrolimus and topical medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2010
- Phase
- Phase 4
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males and females ≥ 2 years old.
- Subjects must be in good general health as confirmed by medical history and physical examination.
- Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine). NOTE: Post-menopausal (amenorrheic for at least one year) and surgically sterile (tubal ligation and/or hysterectomy) are considered to be of non child-bearing potential.
- Clear diagnosis of atopic dermatitis for at least one year.
- Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity) for each selected target lesion
- Disease must be stable or slowly worsening for more than one week prior to entering the study.
- Subjects must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.
Who cannot join
- Females who are pregnant, attempting to conceive, or breastfeeding.
- Subjects with known hypersensitivity to study drug.
- Subjects with overt signs of skin atrophy, telangiectasias and/or striae in the target area.
- Subjects with a current active skin malignancy or infection.
- Subjects requiring the use of medications known to alter the course of atopic dermatitis during the study treatment.
- Subjects who have received systemic antibiotics within 2 weeks.
Show all 11Show fewer
- Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
- Subjects who have received topical corticosteroids or other topical therapies (tar, calcineurin inhibitors) for atopic dermatitis within 7 days of entering the study.
- Subjects using phototherapy (UVB, PUVA) within 28 days of entering the study.
- Subjects who are currently participating in or, with in the previous 28 days, have participated in another study for the treatment of atopic dermatitis.
- Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine Department of Dermatology Clinical Trials
New York, New York, 10029
About this study
The purpose of this study is to assess a bilateral comparison between pimecrolimus cream 1% (Elidel®) and a medical device cream (EletoneTM) in the treatment and management of atopic dermatitis. Study subjects will apply pimecrolimus twice daily for four weeks on a target area located on one side of the body, and apply the medical device cream three times daily for four weeks on the opposite side of the body at a target lesion symmetric to the other.
Read the detailed description
Atopic dermatitis (AD) is a common and chronic inflammatory skin disease that affects a large part of the population. Although atopic dermatitis responds well to twice daily mid-strength corticosteroids, it is not optimal to expose a patient to the long term use of topical corticosteroids. Side effects of long term steroid use include skin atrophy, striae, tachyphylaxis, adrenal suppression, bacterial infections, and contact allergies to name a few. Elidel® (pimecrolimus) cream 1% and Eletone™ cream are both alternative topical therapies FDA approved for use in patients with atopic dermatitis. Each has an independent mechanism of action that has been shown in clinical trials to deliver itch relief, reduce eczema flares and maintain remission, thus providing an adequate treatment option when topical steroids are not preferred or contraindicated. Thus far, no study has evaluated the efficacy of these two products head-to-head. This is an investigator-blinded, bilateral comparison study in 20 subjects with atopic dermatitis. It is designed to assess and compare the efficacy Elidel® (pimecrolimus) cream 1% and Eletone™ cream in patients with atopic dermatitis. Subjects will apply Elidel® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target eczematous area located on one side of the body and then apply Eletone™ three times daily on a symmetrical target eczematous area on the opposite side of the body. A randomized list will be created to determine which side the subject applies each medication. Patients will be clinically evaluated every two weeks by the investigator on a Physician Global Assessment (PGA) scale. Part of this clinical study consists of the use of patient and self-assessment questionnaires and the use of non-identifying digital photography of target lesions.
- Conditions
- Atopic Dermatitis
- Being tested
- pimecrolimus, topical medical device
- Keywords
- Atopic dermatitis, Elidel, pimecrolimus cream 1%, Eletone, medical device cream, topical calcineurin inhibitor
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pimecrolimusDrug
pimecrolimus 1% cream twice daily
topical medical deviceDevice
Eletone cream three times daily
| Study group | Role | What they receive |
|---|---|---|
| pimecrolimus (Elidel) | Active comparator | pimecrolimus twice daily to a chosen target lesion on one side of body Receives: Drug: pimecrolimus |
| topical medical device cream (Eletone) | Active comparator | topical medical device cream three times daily to a chosen target lesion on one side of the body Receives: Device: topical medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Physician Global Assessment (PGA)
Measured: 4 weeks
Secondary outcomes (2)
Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification)
Measured: 4 weeks
Improvement in patient self-assessments
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emer, Jason, M.D.
- Collaborators
- Ferndale Laboratories
- Investigators
- Jason Emer, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177566
- Sponsor's protocol ID
- 08-1450
- Status last verified
- Aug 2010
- First submitted
- 4 Aug 2010
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT01177566
- Acronym / sponsor ID
- 08-1450
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Elidel, pimecrolimus cream 1%, Eletone, medical device cream, topical calcineurin inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emer, Jason, M.D.
- Collaborators
- Ferndale Laboratories
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Aug 2010 (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.
The purpose of this study is to assess a bilateral comparison between pimecrolimus cream 1% (Elidel®) and a medical device cream (EletoneTM) in the treatment and management of atopic dermatitis. Study subjects will apply pimecrolimus twice daily for four weeks on a target area located on one side of the body, and apply the medical device cream three times daily for four weeks on the opposite side of the body at a target lesion symmetric to the other.
Detailed description
Atopic dermatitis (AD) is a common and chronic inflammatory skin disease that affects a large part of the population. Although atopic dermatitis responds well to twice daily mid-strength corticosteroids, it is not optimal to expose a patient to the long term use of topical corticosteroids. Side effects of long term steroid use include skin atrophy, striae, tachyphylaxis, adrenal suppression, bacterial infections, and contact allergies to name a few. Elidel® (pimecrolimus) cream 1% and Eletone™ cream are both alternative topical therapies FDA approved for use in patients with atopic dermatitis. Each has an independent mechanism of action that has been shown in clinical trials to deliver itch relief, reduce eczema flares and maintain remission, thus providing an adequate treatment option when topical steroids are not preferred or contraindicated. Thus far, no study has evaluated the efficacy of these two products head-to-head. This is an investigator-blinded, bilateral comparison study in 20 subjects with atopic dermatitis. It is designed to assess and compare the efficacy Elidel® (pimecrolimus) cream 1% and Eletone™ cream in patients with atopic dermatitis. Subjects will apply Elidel® (pimecrolimus) cream 1% twice daily for four weeks on a chosen target eczematous area located on one side of the body and then apply Eletone™ three times daily on a symmetrical target eczematous area on the opposite side of the body. A randomized list will be created to determine which side the subject applies each medication. Patients will be clinically evaluated every two weeks by the investigator on a Physician Global Assessment (PGA) scale. Part of this clinical study consists of the use of patient and self-assessment questionnaires and the use of non-identifying digital photography of target lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pimecrolimus (Elidel) | Active comparator | Drug: pimecrolimuspimecrolimus twice daily to a chosen target lesion on one side of body |
| topical medical device cream (Eletone) | Active comparator | Device: topical medical devicetopical medical device cream three times daily to a chosen target lesion on one side of the body |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females ≥ 2 years old.
- Subjects must be in good general health as confirmed by medical history and physical examination.
- Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine). NOTE: Post-menopausal (amenorrheic for at least one year) and surgically sterile (tubal ligation and/or hysterectomy) are considered to be of non child-bearing potential.
- Clear diagnosis of atopic dermatitis for at least one year.
- Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity) for each selected target lesion
Key exclusion criteria (11 listed)
- Females who are pregnant, attempting to conceive, or breastfeeding.
- Subjects with known hypersensitivity to study drug.
- Subjects with overt signs of skin atrophy, telangiectasias and/or striae in the target area.
- Subjects with a current active skin malignancy or infection.
- Subjects requiring the use of medications known to alter the course of atopic dermatitis during the study treatment.
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 |
|---|---|---|
| pimecrolimuspimecrolimus 1% cream twice daily | Drug | pimecrolimus (Elidel) |
| topical medical deviceEletone cream three times daily | Device | topical medical device cream (Eletone) |
Primary outcome
Improvement in Physician Global Assessment (PGA)
Time frame: 4 weeks
2 secondary outcomes
Improvement of the signs of atopic dermatitis (erythema, population, infiltration, excoriation and lichenification)
Time frame: 4 weeks
Improvement in patient self-assessments
Time frame: 4 weeks
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 9 Aug 2010.
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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.
Jason Emer, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pimecrolimus and topical medical device in people with Atopic Dermatitis, run by Emer, Jason, M.D. at 1 site 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 7 inclusion and 11 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 9 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Improvement in Physician Global Assessment (PGA) (time frame: 4 weeks). 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 9 Aug 2010.