- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02376049
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
May 1, 2017 updated by: LEO Pharma
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.
Study Overview
Status
Completed
Conditions
Detailed Description
Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pimecrolimus cream
Pimecrolimus 1% cream once daily for 14 days
|
Other Names:
|
Active Comparator: Betamethasone dipropionate cream
Betamethasone dipropionate 0.05% cream once daily for 14 days
|
Other Names:
|
Active Comparator: Clobetasol propionate cream
Clobetasol propionate 0.05% cream once daily for 14 days
|
Other Names:
|
Placebo Comparator: Glaxal Base cream vehicle
Glaxal Base cream vehicle once daily for 14 days
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Sign Score (TSS) change
Time Frame: 14 days
|
TSS change at end of treatment in relation to baseline
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emma Guttmann, MD, Icahn School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
February 25, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Actual)
May 3, 2017
Last Update Submitted That Met QC Criteria
May 1, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Calcineurin Inhibitors
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Betamethasone sodium phosphate
- Clobetasol
- Pimecrolimus
- Emollients
Other Study ID Numbers
- EXP-1184
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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