Back to resultsA Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Pimecrolimus cream
Betamethasone dipropionate cream
Clobetasol propionate cream
Glaxal Base cream vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Eczema, AD
Eligibility Criteria
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
Sites / Locations
- Innovaderm Research Inc.
- Beit Harofim
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Pimecrolimus cream
Betamethasone dipropionate cream
Clobetasol propionate cream
Glaxal Base cream vehicle
Arm Description
Pimecrolimus 1% cream once daily for 14 days
Betamethasone dipropionate 0.05% cream once daily for 14 days
Clobetasol propionate 0.05% cream once daily for 14 days
Glaxal Base cream vehicle once daily for 14 days
Outcomes
Primary Outcome Measures
Total Sign Score (TSS) change
TSS change at end of treatment in relation to baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02376049
Brief Title
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
Official Title
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.
Detailed Description
Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Eczema, AD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pimecrolimus cream
Arm Type
Active Comparator
Arm Description
Pimecrolimus 1% cream once daily for 14 days
Arm Title
Betamethasone dipropionate cream
Arm Type
Active Comparator
Arm Description
Betamethasone dipropionate 0.05% cream once daily for 14 days
Arm Title
Clobetasol propionate cream
Arm Type
Active Comparator
Arm Description
Clobetasol propionate 0.05% cream once daily for 14 days
Arm Title
Glaxal Base cream vehicle
Arm Type
Placebo Comparator
Arm Description
Glaxal Base cream vehicle once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus cream
Other Intervention Name(s)
Elidel
Intervention Type
Drug
Intervention Name(s)
Betamethasone dipropionate cream
Other Intervention Name(s)
Diprosone, Diprolene
Intervention Type
Drug
Intervention Name(s)
Clobetasol propionate cream
Other Intervention Name(s)
Dermovate
Intervention Type
Drug
Intervention Name(s)
Glaxal Base cream vehicle
Other Intervention Name(s)
emollient cream
Primary Outcome Measure Information:
Title
Total Sign Score (TSS) change
Description
TSS change at end of treatment in relation to baseline
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Guttmann, MD
Organizational Affiliation
Icahn School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Beit Harofim
City
Netanya
ZIP/Postal Code
42701
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
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