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CompletedNCT01202149Updated Apr 15, 2011

Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis

A Phase 4 interventional study of Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device) in Eczema and Atopic Dermatitis, sponsored by Frankel, Amylynne, M.D.. Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2011-04-15.

Sponsored by Frankel, Amylynne, M.D. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Eczema
  • Atopic Dermatitis

Keywords

  • eczema
  • elidel
  • non-medicated device
  • hylatopic plus
  • pimecrolimus
  • bilateral comparison study
  • topical therapy
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Frankel, Amylynne, M.D. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Elidel Right Side, Hylatopic Plus Left Side

    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

    Device: Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)

  • Active comparator
    Elidel Left Side Hylatopic Plus Right Side

    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

    Device: Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)

Interventions

  • DeviceElidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)
06

What researchers measure

Primary outcomes

  1. Improvement and maintenance of PGA, TLSS, and subjective eczema control of Hylatopic Plus Emollient Foam versus Elidel Cream

    Time frame: 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

07

Study locations

1 site
  • Mount Sinai Faculty Practice Associates
    New York, New York 10029, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01202149
Lead sponsor
Frankel, Amylynne, M.D.
Collaborators
Onset Therapeutics, Inc
First posted
Sep 15, 2010
Start date
Mar 2010
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Apr 15, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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