Actively Recruiting
Study Comparing Efficacy and Tolerability of Two Emollient Creams (New Product vs Placebo) for Atopic Dermatitis
Led by NAOS Les Laboratoires · Updated on 2025-04-16
64
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating and comparing the effectiveness and tolerability of two face and body cream products, a new emollient versus a placebo, in adults with atopic dermatitis (AD). AD is a chronic inflammatory skin condition characterized by redness, scaly and oozing plaques, and intense itching, which significantly affects quality of life and sleep. The disease has flare-up and remission phases and involves immune system issues, skin barrier defects, skin microbiota imbalance, and inflammation. Participants will use either the new emollient or a placebo cream for five weeks, replacing their usual emollient treatments. This study is interventional, single-center, double-blind, randomized, and comparative, involving both male and female subjects. The treatments are topical creams applied to the skin, focusing on areas requiring corticosteroid treatment. During the study, participants will be assessed on several measures at three time points: Day 0, between Day 5 and Day 10, and approximately 28 days after Day 5 to 10. These assessments include the SCORAD and EASI scales to evaluate eczema severity, transepidermal water loss measurements, skin microbiota samples, quality of life questionnaires, sleep quality questionnaires, and safety monitoring. The total participation involves monitoring skin condition, symptoms, and safety throughout the treatment period.
CONDITIONS
Official Title
Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female and/or male participants
- Aged 18 years or older
- All ethnicities
- Skin phototype II to IV
- Any skin type, sensitive or not
- 44 subjects with eczema rash (SCORAD between 25 and 50) needing topical corticosteroid treatment
- 22 healthy subjects without skin disorders
- 44 participants with whitened eczema lesions 5 to 10 days after corticosteroid treatment
- Signed informed consent and photo authorization
- Able to follow the study protocol and requirements
You will not qualify if you...
- Not meeting the inclusion criteria
- Pregnant, breastfeeding, or unwilling to avoid pregnancy during the study
- Other dermatological problems in test areas besides atopic dermatitis
- Use of medications affecting skin metabolism, including antibiotics within 4 weeks or anti-inflammatories within 2 weeks before inclusion
- Under legal custody, guardianship, or deprived of liberty
- Unable to consent or comply due to language or psychological issues
- Significant health changes incompatible with study inclusion
- Currently enrolled in a similar clinical study or within exclusion period
- Recent sun exposure, tanning product use, or tanning activators within 2 weeks before inclusion
- Bathing in a swimming pool within 1 week before inclusion or planning to during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ltd Health
Batumi, Adjara, Georgia, 6000
Actively Recruiting
Research Team
L
Lela BERIDZE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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