Efficacy and safety of two moisturising creams for maintenance treatment of atopic dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Galenica AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

26 Jan 2026 → ongoing

Decision date (initial)

2025-11-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To demonstrate superiority in time to relapse of eczema with moisturisers Oviderm cream and Urea/propylene glycol cream, respectively, as compared to non-treatment

Secondary objectives 4

1. To evaluate time to relapse of eczema with moisturiser Oviderm cream as compared to Urea/propylene glycol cream
2. To evaluate pruritus reduction with moisturisers Oviderm cream and Urea/propylene glycol cream, respectively, as compared to non-treatment
3. To evaluate pruritus reduction with moisturisers Oviderm cream compared to Urea/propylene glycol cream
4. To evaluate the safety of treatment with Oviderm cream and Urea/propylene glycol cream

Conditions and MedDRA coding

Atopic Dermatitis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. • The patient has given their written consent to participate in the study
2. • Age ≥ 18 years
3. • Patients with known AD or diagnosed with AD according to the Williams criteria [1] with visible atopic lesions on arms and/or legs. Two lesions on left respective right side with a size of 2 x 2 cm to 10 x 10 cm should be available, i.e., study areas. The largest lesion should not be more than 50% larger than the smallest lesion in length and width, i.e., the length of the largest selected lesion ≤ 1.5× the length of the smallest and the width of the largest selected lesion ≤ 1.5× width of the smallest lesion
4. • Moderate to severe form of AD, IGA ≥ 3 [2], a mEASI score on the defined study areas of ≥ 4 and with a difference between left study area to right study area of ≤ 1 and which, in the opinion of the Investigator, can achieve complete clearance with a class III corticosteroid treatment for approximately 4 weeks

Exclusion criteria 9

1. • Eczema exclusively on the hands
2. • Patients assessed by the Investigator to have mild atopic dermatitis
3. • Patients treated for AD with systemic drugs, topical corticosteroids class IV and light treatment during the last 3 months
4. • Any concomitant medications that, in the opinion of the Investigator, could affect the study outcome
5. • Known sensitivity or allergy to any of the study products
6. • Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (e.g., compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments or procedures
7. • Patients assessed by the Investigator to have poor compliance
8. • Patients assessed by the Investigator to have difficulty reading and understanding the local language
9. • Patients who are pregnant, breast feeding or planning to become pregnant during study participation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Time to relapse of eczema (patient reported outcome [PRO]) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first

Secondary endpoints 4

1. • Time to relapse of eczema (PRO) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first
2. • Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS)
3. • Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS) per time
4. • Frequency of adverse events during the maintenance phase

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Galenica AB

Sponsor organisation

Galenica AB

Address

Medeon Science Park

City

Malmo

Postcode

205 12

Country

Sweden

Scientific contact point

Organisation

Galenica AB

Contact name

Joakim

Public contact point

Organisation

Galenica AB

Contact name

Joakim

Third parties 2

Locations

2 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 36 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications