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NCT01202149 · ClinicalTrials.gov registry record · Phase 4
Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis
A Phase 4 study of Atopic Dermatitis and Eczema, sponsored by Frankel, Amylynne, M.D..
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01202149 is a Phase 4 study of Atopic Dermatitis and Eczema that has completed, run by Frankel, Amylynne, M.D.. The registered enrollment target is 30 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01202149, a Phase 4 study of Atopic Dermatitis and Eczema, has completed, sponsored by Frankel, Amylynne, M.D..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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 fo
Conditions Studied
Interventions
- DEVICE Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)
Study Locations (1)
New York
- Mount Sinai Faculty Practice Associates - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-11 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01202149
The ClinicalTrials.gov registry entry for NCT01202149 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (95% lower). The listed sponsor is Frankel, Amylynne, M.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device) is the first listed.
NCT01202149 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01202149 about?
NCT01202149 is a clinical study titled "Bilateral Comparison Study of Elidel 1% and Hylatopic Plus Emollient Foam for 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) c...
What is the current status of trial NCT01202149?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2010-03. Estimated completion is 2010-11.
What conditions does trial NCT01202149 study?
This clinical trial studies the following conditions: Atopic Dermatitis, Eczema.
What interventions are being tested in trial NCT01202149?
The interventions under investigation include: Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device) (DEVICE).
Who is sponsoring clinical trial NCT01202149?
This trial is sponsored by Frankel, Amylynne, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01202149 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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