URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis
ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCEN Biotech
About this trial
The goal of this clinical study is to determine whether URGO FilmoCream Eczema is effective as a non-steroidal treatment to relieve symptoms of atopic dermatitis. It also aims to evaluate the cream's ability to moisturize, soothe irritation, protect the skin, and promote healing of eczema lesions. The main questions the study seeks to answer are:
1. Does URGO FilmoCream Eczema improve symptom relief of atopic dermatitis when used alongside standard topical corticosteroid treatment? 2. How do eczema lesions treated with topical corticosteroids alone progress and heal compared to those treated with topical corticosteroids plus URGO FilmoCream Eczema? To investigate this, patients with at least two similar eczema lesions are enrolled. One lesion is treated with topical corticosteroids alone, while the other is treated with topical corticosteroids plus URGO FilmoCream Eczema.
The progression of both lesions is monitored throughout treatment, until healing, and for 28 days after the last application of topical corticosteroids.
Eligibility criteria
Qualifiers
Male or female subject.
Aged 18 or more.
With mild to moderate atopic dermatitis based on the Investigator's Global Assessment for Atopic Dermatitis (IGA-AD).
Presence of two comparable atopic dermatitis lesions requiring treatment with topical corticosteroids, located at anatomically distant sites.
Disqualifiers
Subject currently participating in another clinical study that may interfere with the assessments of the present study, according to the investigator's judgment.
Subject unable to understand the information provided - including study procedures - due to linguistic or psychiatric reasons, and therefore unable to give written informed consent or to complete the study diary as required.
Subject who, in the investigator's judgment, is unlikely to comply with study-related constraints and requirements.
Subject who has forfeited his/her freedom by administrative or legal decision, or who is under legal guardianship.
Trial design
Treatments tested in this trial
- Treatment period with dermocorticoid alone
- Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid
- Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid
- Follow-up period after dermocorticoid treatment alone
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
CEN Biotech
Lead sponsor
Eurofins Dermscan Pharmascan
Collaborator
URGO Recherche, Innovation et Développement
Collaborator
Source ClinicalTrials.gov