A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)

February 21, 2025 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

Intervention / Treatment

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.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research Inc.
  • Israel
      • Netanya, Israel, 42701
        • Beit Harofim

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

Yes

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
Drug: Pimecrolimus cream
Other Names:
  • Elidel
Active Comparator: Betamethasone dipropionate cream
Betamethasone dipropionate 0.05% cream once daily for 14 days
Drug: Betamethasone dipropionate cream
Other Names:
  • Diprosone
  • Diprolene
Active Comparator: Clobetasol propionate cream
Clobetasol propionate 0.05% cream once daily for 14 days
Drug: Clobetasol propionate cream
Other Names:
  • Dermovate
Placebo Comparator: Glaxal Base cream vehicle
Glaxal Base cream vehicle once daily for 14 days
Drug: Glaxal Base cream vehicle
Other Names:
  • emollient cream

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

LEO Pharma

Investigators

  • Principal Investigator: Emma Guttmann, MD, Icahn School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXP-1184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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