EczemaPhase 4NCT01202149
Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis
A Phase 4 study testing Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device) in people with Eczema and Atopic Dermatitis, run by Frankel, Amylynne, M.D. at 1 site in United States.
Trial summary
This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream 1% and Hylatopic™ Plus Emollient Foam™ in subjects with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Eczema, Atopic Dermatitis
- What is being tested?
- Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 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
- No healthy volunteers
- 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.
- Diagnosis of atopic dermatitis for at least one year with symptoms on arms, trunk, and/or legs.
- Subject must have a static Investigator's Global Assessment (IGA) of at least 2 or 3 (mild-moderate severity) for each selected target lesion
- Disease must be stable or slowly worsening for more than one week prior to the Screening Visit, as reported by the subject.
- Subjects or their guardians 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 either study drug.
- Subjects with AD on >30% body surface area
- 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.
Show all 12Show fewer
- Subjects who have received systemic antibiotics within 2 weeks.
- Subjects using systemic corticosteroids or immunosuppressants within 28 days of the Screening Visit.
- Subjects who have received topical corticosteroids or other topical therapies (tar, calcineurin inhibitors) for atopic dermatitis within 7 days of the Screening Visit.
- Subjects using phototherapy (UVB, PUVA) within 28 days of the Screening Visit.
- 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 pose 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 Faculty Practice Associates
New York, New York, 10029
About this study
Official title: Bilateral Comparison Study of Elidel® (Pimecrolimus) Cream 1% and Hylatopic™ Plus Emollient Foam™ Emollient Foam in the Treatment of Subjects With Atopic Dermatitis
This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream 1% and Hylatopic™ Plus Emollient Foam™ in subjects 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 Hylatopic™ Plus Emollient Foam™ 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.
Subjects will be consented prior to any study evaluations or procedures. After signing the consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected areas for four weeks. Photography will be used to record the location of target lesions at the baseline, week two and week four/final visits. Subject's disease status will be assessed by two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom Score (TLSS) (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline (Day 0), week two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for each of the target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well.
Additionally, subjects' self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion. This assessment will be made using a four point scale and Itch Severity Scale (visual analogue score) respectively (see section V.B.4). Lastly, subjects will take a Product Preference Survey at week 4/final visit (Day 28 +/- 2days). Parents (or guardians) will moderate Product Preference Surveys for subjects that are younger than 12 years of age.
Read the detailed description
This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream 1% and Hylatopic™ Plus Emollient Foam™ in subjects 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 Hylatopic™ Plus Emollient Foam™ 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.
Subjects will be consented prior to any study evaluations or procedures. After signing the consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected areas for four weeks. Photography will be used to record the location of target lesions at the baseline, week two and week four/final visits. Subject's disease status will be assessed by two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom Score (TLSS) (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline (Day 0), week two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for each of the target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well.
Additionally, subjects' self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion. This assessment will be made using a four point scale and Itch Severity Scale (visual analogue score) respectively (see section V.B.4). Lastly, subjects will take a Product Preference Survey at week 4/final visit (Day 28 +/- 2days). Parents (or guardians) will moderate Product Preference Surveys for subjects that are younger than 12 years of age.
- Conditions
- Eczema, Atopic Dermatitis
- Being tested
- Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)
- Keywords
- eczema, elidel, non-medicated device, hylatopic plus, pimecrolimus, bilateral comparison study, topical therapy
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)Device
| Study group | Role | What they receive |
|---|---|---|
| Elidel Right Side, Hylatopic Plus Left Side | Active comparator | Elidel applied topically on Right Side of body twice a day and Hylatopic plus emollient foam applied topically on Left Side of body three times a day Receives: Device: Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device) |
| Elidel Left Side Hylatopic Plus Right Side | Active comparator | Elidel applied topically on Left Side of body twice a day and Hylatopic plus emollient foam applied topically on Right Side of body three times a day Receives: Device: Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement and maintenance of PGA, TLSS, and subjective eczema control of Hylatopic Plus Emollient Foam versus Elidel Cream
Measured: 26 weeks
Secondary outcomes (1)
Improvement and maintenance of signs of eczema
Improvement and maintenance of signs of eczema (erythema, population/infiltration, lichenification, and scaling/dryness) with twice daily Elidel applied topically to one side of the body as compared to three times days Hylatopic Plus applied topically to the other side of the body; Assessment for any clinical signs of atrophy or telangiectasia; Improvement in patient self-assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frankel, Amylynne, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Onset Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202149
- Sponsor's protocol ID
- 09-0879
- Status last verified
- Apr 2011
- First submitted
- 14 Sep 2010
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Comparison Study of Elidel® (Pimecrolimus) Cream 1% and Hylatopic™ Plus Emollient Foam™ Emollient Foam in the Treatment of Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01202149
- Acronym / sponsor ID
- 09-0879
- Conditions
- Eczema, Atopic Dermatitis
- Keywords
- eczema, elidel, non-medicated device, hylatopic plus, pimecrolimus, bilateral comparison study, topical therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Frankel, Amylynne, M.D.University, hospital or other
- Collaborators
- Onset Therapeutics, Inc
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Sep 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.
This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream 1% and Hylatopic™ Plus Emollient Foam™ in subjects 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 Hylatopic™ Plus Emollient Foam™ 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.
Subjects will be consented prior to any study evaluations or procedures. After signing the consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected areas for four weeks. Photography will be used to record the location of target lesions at the baseline, week two and week four/final visits. Subject's disease status will be assessed by two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom Score (TLSS) (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline (Day 0), week two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for each of the target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well.
Additionally, subjects' self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion. This assessment will be made using a four point scale and Itch Severity Scale (visual analogue score) respectively (see section V.B.4). Lastly, subjects will take a Product Preference Survey at week 4/final visit (Day 28 +/- 2days). Parents (or guardians) will moderate Product Preference Surveys for subjects that are younger than 12 years of age.
Detailed description
This is an investigator-blinded, bilateral comparison study in 30 subjects with atopic dermatitis. It is designed to assess and compare the efficacy of Elidel® (pimecrolimus) cream 1% and Hylatopic™ Plus Emollient Foam™ in subjects 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 Hylatopic™ Plus Emollient Foam™ 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.
Subjects will be consented prior to any study evaluations or procedures. After signing the consent and meeting all inclusion/exclusion criteria, qualified and enrolled subjects will apply study medication (Elidel® and Hylatopic™ Plus Emollient Foam™) to chosen affected areas for four weeks. Photography will be used to record the location of target lesions at the baseline, week two and week four/final visits. Subject's disease status will be assessed by two methods: 1) Physician's Global Assessment (PGA) and 2) Target Lesion Symptom Score (TLSS) (see sections V.B.2 and V.B.3). PGA as well as TLSS will be made at baseline (Day 0), week two (Day 14 +/- 2 days) and week 4/final visit (Day 28 +/- 2days) visits for each of the target lesions. Half scales (i.e. 0.5, 1.5) will not be used. The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well.
Additionally, subjects' self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion. This assessment will be made using a four point scale and Itch Severity Scale (visual analogue score) respectively (see section V.B.4). Lastly, subjects will take a Product Preference Survey at week 4/final visit (Day 28 +/- 2days). Parents (or guardians) will moderate Product Preference Surveys for subjects that are younger than 12 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elidel Right Side, Hylatopic Plus Left Side | Active comparator | Device: Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)Elidel applied topically on Right Side of body twice a day and Hylatopic plus emollient foam applied topically on Left Side of body three times a day |
| Elidel Left Side Hylatopic Plus Right Side | Active comparator | Device: Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)Elidel applied topically on Left Side of body twice a day and Hylatopic plus emollient foam applied topically on Right Side of body three times a day |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not 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.
- Diagnosis of atopic dermatitis for at least one year with symptoms on arms, trunk, and/or legs.
- Subject must have a static Investigator's Global Assessment (IGA) of at least 2 or 3 (mild-moderate severity) for each selected target lesion
Key exclusion criteria (12 listed)
- Females who are pregnant, attempting to conceive, or breastfeeding.
- Subjects with known hypersensitivity to either study drug.
- Subjects with AD on >30% body surface area
- Subjects with overt signs of skin atrophy, telangiectasias and/or striae in the target area.
- Subjects with a current active skin malignancy or infection.
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 |
|---|---|---|
| Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device) | Device | Elidel Left Side Hylatopic Plus Right Side, Elidel Right Side, Hylatopic Plus Left Side |
Primary outcome
Improvement and maintenance of PGA, TLSS, and subjective eczema control of Hylatopic Plus Emollient Foam versus Elidel Cream
Time frame: 26 weeks
1 secondary outcome
Improvement and maintenance of signs of eczema
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 15 Apr 2011.
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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.
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 Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device) in people with Eczema and Atopic Dermatitis, run by Frankel, Amylynne, 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 12 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 15 Apr 2011. 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 and maintenance of PGA, TLSS, and subjective eczema control of Hylatopic Plus Emollient Foam versus Elidel Cream (time frame: 26 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 15 Apr 2011.