Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02376049 |
Date of registration:
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25/02/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
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Scientific title:
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An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis |
Date of first enrolment:
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February 2015 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02376049 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Israel
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Contacts
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Name:
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Emma Guttmann, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject with mild to moderate AD
- Four comparable TAs
- TSS of at least 5 on all TAs
- Difference in TSS not greater than 2 between the TAs
- Sign score erythema = 2 between the TAs
- TAs should be at least 2 cm apart
Exclusion Criteria:
- Investigator's opinion
- Fitzpatrick skin type >5
- Topical (i.e. on the TAs) treatment with prohibited medications
- Systemic treatment with prohibited medications
- Phototherapy within prohibited timeframe
- Use of emollients within prohibited timeframe
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Drug: Clobetasol propionate cream
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Drug: Glaxal Base cream vehicle
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Drug: Pimecrolimus cream
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Drug: Betamethasone dipropionate cream
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Primary Outcome(s)
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Total Sign Score (TSS) change
[Time Frame: 14 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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