A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis
1 other identifier
interventional
30
2 countries
2
Brief Summary
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2015
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFebruary 24, 2025
May 1, 2017
5 months
February 25, 2015
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Sign Score (TSS) change
TSS change at end of treatment in relation to baseline
14 days
Study Arms (4)
Pimecrolimus cream
ACTIVE COMPARATORPimecrolimus 1% cream once daily for 14 days
Betamethasone dipropionate cream
ACTIVE COMPARATORBetamethasone dipropionate 0.05% cream once daily for 14 days
Clobetasol propionate cream
ACTIVE COMPARATORClobetasol propionate 0.05% cream once daily for 14 days
Glaxal Base cream vehicle
PLACEBO COMPARATORGlaxal Base cream vehicle once daily for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (2)
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5, Canada
Beit Harofim
Netanya, 42701, Israel
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emma Guttmann, MD
Icahn School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
February 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
February 24, 2025
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share