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

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LEO Pharma

Status and phase

Completed
Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: LEO 39652 cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT02219633
LP0083-1085
2014-000849-80 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

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
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

LEO 39652 cream
Experimental group
Description:
Topical application
Treatment:
Drug: LEO 39652 cream
LEO 39652 cream vehicle
Placebo Comparator group
Description:
Topical application
Treatment:
Drug: LEO 39652 cream

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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