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

NCT02496546 | Completed Phase 1

• 2 other identifiers: LP0108-10822014-000519-15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total sign score on limited treatment area on entire treatment area during trial

  3 week

• Investigator's treatment area assessment of disease severity on entire treatment area during trial

  3 weeks

• Subject's treatment area assessment of disease severity on entire treatment area during trial

  3 weeks

• Subject's assessment of itching on entire treatment area during trial

  3 weeks

• Transepidermal water loss during trial

  3 weeks

Study Arms (2)

LEO 32731 cream

EXPERIMENTAL

Topical application

Drug: LEO 32731 cream

LEO 32731 cream vehicle

PLACEBO COMPARATOR

Topical application

Drug: LEO 32731 cream vehicle

Interventions

LEO 32731 cream DRUG

Applied for 3 weeks

LEO 32731 cream

LEO 32731 cream vehicle DRUG

Applied for 3 weeks

LEO 32731 cream vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Proinnovera GmbH, Center of Dermatology Excellence

Münster, 48159, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

DE (1)