Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis

Launched by NAOS LES LABORATOIRES · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to compare the effectiveness and tolerability of two different skin creams for people with atopic dermatitis, a condition that causes red, itchy, and flaky skin. The study will involve using a new emollient cream versus a placebo (which is a cream with no active ingredients) for five weeks. Participants will include both men and women aged 18 and older who have atopic dermatitis with specific skin conditions, as well as a smaller group of healthy individuals without any skin issues.

If you decide to participate, you'll be asked to apply the cream as directed and attend follow-up appointments to monitor your skin's response. The study aims to learn more about how well these creams work and how comfortable they are to use. It’s important to know that there are some criteria for joining, such as not being pregnant or breastfeeding and not having other skin conditions in the areas being treated. Participants will need to sign a consent form to take part in the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.