Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

NCT02219633 | Completed Phase 1

• 2 other identifiers: LP0083-10852014-000849-80
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 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

  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 assessed area.

  22 days

Secondary Outcomes (5)

• Total sign score on limited treatment area

  22 days

• Investigator's treatment area assessment of disease severity

  22 days

• Subject´s treatment area assessment of disease severity

  22 days

• Subject´s assessment of itching

  22 days

• Transepidermal Water Loss

  22 days

Study Arms (2)

LEO 39652 cream

EXPERIMENTAL

Topical application

Drug: LEO 39652 cream

LEO 39652 cream vehicle

PLACEBO COMPARATOR

Topical application

Drug: LEO 39652 cream

Interventions

LEO 39652 cream DRUG

Applied for 21 days

LEO 39652 cream; LEO 39652 cream vehicle

Eligibility Criteria

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

You may qualify if:

• Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3)
• Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part)
• Subjects must be in good health
• Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception

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
• Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments
• Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
• Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

proinnovera GmbH, Center of Dermatology Excellence

Münster, 48159, Germany

Location

Related Links

• Clinical Trials at LEO Pharma

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 Officials

• Lydia Graßhoff, MD

  Proinnovera GmbH

  PRINCIPAL INVESTIGATOR

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: August 13, 2014
• First Posted: August 19, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 24, 2025

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)