Status:
RECRUITING
Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis
Lead Sponsor:
NAOS Les Laboratoires
Conditions:
Atopic Dermatitis
Eczema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with erythema, scaly and oozing plaques, and severe pruritus which has an important impact on quality of life and quality of sl...
Eligibility Criteria
Inclusion
- Female and/or male participants,
- Participant aged between 18 years old and more included,
- All ethnicities
- Phototype II to IV
- Participant with all skin types, sensitive or not sensitive,
- 44 subjects having a rash of eczema (SCORAD between 25 and 50) with at least 1 lesional area requiring topical corticosteroid treatment,
- 22 healthy subjects (without any dermatological pathology nor disorder),
- 44 participants having whitened eczema lesions at Dx (between 5 to 10 days) after the topical corticosteroid treatment,
- Participants having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization,
- Participant able to comply with the protocol and follow protocol's constraints and specific requirements.
Exclusion
- Participant does not meet the inclusion criteria,
- Known pregnancy, participant breastfeeding, or not willing to take necessary precautions to avoid a pregnancy during the study,
- Participant with dermatological problems in the test areas other than atopic dermatitis,
- Pharmacological treatments (topic or systemic) other than topical corticosteroids, known to interfere with skin metabolism / physiology. In particular, no antibiotics taken within 4 weeks preceding the inclusion, nor anti- inflammatories taken within 2 weeks before the inclusion
- Participant being deprived of liberty by judicial or administrative decision, or under guardianship,
- Participant being linguistically or psychologically incapable of signing informed consent and unable to comply with the protocol requirements,
- Participant who has a relevant change in his state of health since registered in the LTD "Health" Database (change incompatible with inclusion in the study),
- Participant currently enrolled in another similar clinical study or in an exclusion period of a study,
- Participant having a skin recently exposed to sunlight (natural or artificial) and / or having applied a self-tanner on the application areas and /or tanning activator (dietary supplement) within 2 weeks preceding the inclusion.
- Participant having bathed in a swimming pool within 1 week preceding the inclusion or planning to bath in a swimming pool during the study.
Key Trial Info
Start Date :
December 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 18 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06930365
Start Date
December 9 2024
End Date
July 18 2025
Last Update
April 16 2025
Active Locations (1)
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1
Ltd Health
Batumi, Adjara, Georgia, 6000