search
Back to results

An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LEO 32731 cream
LEO 32731 cream vehicle
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out
  • Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
  • Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs

Exclusion Criteria:

  • Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than Atopic Dermatitis), sunburn, hyper- or hypopigmentation, scars

Sites / Locations

  • Proinnovera GmbH, Center of Dermatology Excellence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LEO 32731 cream

LEO 32731 cream vehicle

Arm Description

Topical application

Topical application

Outcomes

Primary Outcome Measures

Total sign score at end of treatment on entire treatment area
Total sign score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores (erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness) for each area

Secondary Outcome Measures

Total sign score on limited treatment area on entire treatment area during trial
Investigator's treatment area assessment of disease severity on entire treatment area during trial
Subject's treatment area assessment of disease severity on entire treatment area during trial
Subject's assessment of itching on entire treatment area during trial
Transepidermal water loss during trial
Individual signs score on entire treatment during trial

Full Information

First Posted
July 9, 2015
Last Updated
May 1, 2017
Sponsor
LEO Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT02496546
Brief Title
An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Official Title
An Explorative Trial Evaluating the Effect of LEO 32731 Cream 20 mg/g in Adults With Mild to Moderate Atopic Dermatitis (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (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
The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 32731 cream
Arm Type
Experimental
Arm Description
Topical application
Arm Title
LEO 32731 cream vehicle
Arm Type
Placebo Comparator
Arm Description
Topical application
Intervention Type
Drug
Intervention Name(s)
LEO 32731 cream
Intervention Description
Applied for 3 weeks
Intervention Type
Drug
Intervention Name(s)
LEO 32731 cream vehicle
Intervention Description
Applied for 3 weeks
Primary Outcome Measure Information:
Title
Total sign score at end of treatment on entire treatment area
Description
Total sign score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores (erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness) for each area
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Total sign score on limited treatment area on entire treatment area during trial
Time Frame
3 week
Title
Investigator's treatment area assessment of disease severity on entire treatment area during trial
Time Frame
3 weeks
Title
Subject's treatment area assessment of disease severity on entire treatment area during trial
Time Frame
3 weeks
Title
Subject's assessment of itching on entire treatment area during trial
Time Frame
3 weeks
Title
Transepidermal water loss during trial
Time Frame
3 weeks
Title
Individual signs score on entire treatment during trial
Time Frame
3 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1) Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs Exclusion Criteria: Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than Atopic Dermatitis), sunburn, hyper- or hypopigmentation, scars
Facility Information:
Facility Name
Proinnovera GmbH, Center of Dermatology Excellence
City
Münster
ZIP/Postal Code
48159
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

We'll reach out to this number within 24 hrs