CompletedNCT02219633Updated Feb 24, 2025

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

A Phase 1 interventional study of LEO 39652 cream in Atopic Dermatitis, sponsored by LEO Pharma. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by LEO Pharma · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Atopic Dermatitis

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In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 30 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Experimental
LEO 39652 cream
Topical application
Drug: LEO 39652 cream
Placebo comparator
LEO 39652 cream vehicle
Topical application
Drug: LEO 39652 cream

Interventions

DrugLEO 39652 cream
Applied for 21 days

What researchers measure

Primary outcomes

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.
Time frame: 22 days

Secondary outcomes

Total sign score on limited treatment area
Time frame: 22 days
Investigator's treatment area assessment of disease severity
Time frame: 22 days
Subject´s treatment area assessment of disease severity
Time frame: 22 days
Subject´s assessment of itching
Time frame: 22 days
Transepidermal Water Loss
Time frame: 22 days

Study locations

1 site

proinnovera GmbH, Center of Dermatology Excellence
Münster, 48159, Germany

References and documents

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02219633
Lead sponsor: LEO Pharma
Responsible party: Sponsor
First posted: Aug 19, 2014
Start date: Jul 2014
Primary completion: Dec 2014
Completion: Jan 2015
Last update: Feb 24, 2025

Study contacts

Lydia Graßhoff, MD

principal investigator · Proinnovera GmbH

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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