Comparing two emollient creams for treating atopic dermatitis
Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products (Investigational Product Versus Placebo) In Atopic Dermatitis
This study is testing a new cream for eczema to see if it works better than a fake cream in helping people feel better over five weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NAOS Les Laboratoires Industry-sponsored |
| Locations | 1 site (Batumi, Adjara) |
| Trial ID | NCT06930365 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and tolerability of two emollient products in patients with atopic dermatitis over a period of five weeks. It is a single-center, double-blind, randomized study involving both male and female participants aged 18 and older. The study compares a new emollient cream against a placebo in individuals with eczema, specifically targeting those with a SCORAD score between 25 and 50. Participants will replace their usual emollient with the study products to assess improvements in their skin condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with moderate atopic dermatitis requiring topical corticosteroid treatment.
Not a fit: Patients with severe atopic dermatitis or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from atopic dermatitis.
How similar studies have performed: Previous studies have shown promising results in comparing emollient treatments for atopic dermatitis, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Batumi, Adjara
- Ltd Health — Batumi, Adjara, Georgia (Recruiting)
Study contacts
- Study coordinator: Lela BERIDZE
- Email: lelbe1@rambler.ru
- Phone: (+995) 59140 90 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.