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

Atopic Dermatitis Clinical Trial

Official title:

An Explorative Trial Evaluating the Effect of LEO 32731 Cream 20 mg/g in Adults With Mild to Moderate Atopic Dermatitis (AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496546
• Other study ID #: LP0108-1082
• Secondary ID: 2014-000519-15
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2015
• Last updated: May 1, 2017
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LEO 32731 cream
Applied for 3 weeks
• LEO 32731 cream vehicle
Applied for 3 weeks

Locations

Country	Name	City	State
Germany	Proinnovera GmbH, Center of Dermatology Excellence	Münster

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 weeks
Secondary	Total sign score on limited treatment area on entire treatment area during trial		3 week
Secondary	Investigator's treatment area assessment of disease severity on entire treatment area during trial		3 weeks
Secondary	Subject's treatment area assessment of disease severity on entire treatment area during trial		3 weeks
Secondary	Subject's assessment of itching on entire treatment area during trial		3 weeks
Secondary	Transepidermal water loss during trial		3 weeks
Secondary	Individual signs score on entire treatment during trial		3 weeks

External Links

•   Clinical Trials at LEO Pharma