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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 sleep. It is divided into 2 chronic phases : flare-up and remission period.
Signs and symptoms of AD are associated with a compromised immune system, a defective skin barrier, a cutaneous dysbiosis and overall inflammatory status.
The aim of the study is to evaluate and compare the efficacy and tolerability of two face and body cream products, new emollient versus placebo, in used over the course of 5 weeks as a replacement of usual or any emollient by female and male subjects with atopic dermatitis.
This is an interventional, single-center, double-blind, randomized and comparative study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amr 1: New Emollient | Experimental | Study product, Emollient. Face and body |
|
| Arm 2: Placebo | Placebo Comparator | Product 2: Placebo, Emollient. face and body |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-itching and repairing treatment. Emollient. | Other | Anti-itching and repairing treatment. Emollient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD (SCOring Atopic Dermatisis) | SCORAD (SCOring Atopic Dermatisis). The SCORAD (Scoring Atopic Dermatitis) scale ranges from a minimum score of 0 to a maximum score of 103, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis. | Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours) |
| EASI (Eczema Area and Severity Index) | EASI (Eczema Area and Severity Index). The EASI (Eczema Area and Severity Index) ranges from 0 to 72, where higher scores indicate more severe atopic dermatitis, with 0 meaning no eczema and 72 representing the most severe form. | Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours) |
| Transepidermal water loss by Vapometer® | Transepidermal water loss by Vapometer® (on a defined AD lesion and on non-lesional area to the forearm)) | Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours) |
| Samplings of the cutaneous microbiota | Samplings of the cutaneous microbiota on one or two defined AD lesion. If the subject presents 2 AD lesions, 2 microbiota samples will be done. | Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours) |
| Filling of a DLQI questionnaires by participants | The DLQI (Dermatology Life Quality Index) ranges from 0 to 30, with higher scores indicating a greater impact of skin disease on quality of life. A score of 0-1 suggests no effect, while 30 indicates maximum impact. | Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours) |
| Sleep quality by questionnaire (Pittsburgh Sleep Quality Index) filled in by participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lela BERIDZE | Contact | (+995) 59140 90 90 | lelbe1@rambler.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ltd Health | Recruiting | Batumi | Adjara | 6000 | Georgia |
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Interventional , monocentric, double-blinded, randomized and comparative study. The study design is randomized: Enrolled participants will apply the new emollient versus placebo according to a previous defined randomization scheme.
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Double-blind
| Emollient cream | Other | Emollient cream |
|
The Pittsburgh Sleep Quality Index (PSQI) ranges from 0 to 21, with higher scores indicating poorer sleep quality. A score above 5 suggests poor sleep, while a score of 0 indicates good sleep quality.
| Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours) |
| Safety Endpoints | Incidence, severity and causality of adverse events and serious adverse events Dermatological tolerance evaluation by clinical examination of the physical and functional signs done by a dermatologist | Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours) |
| Safety Endpoints | Incidence, severity and causality of adverse events and serious adverse events Tolerance feedback by participants by Daily log (filled in by participants during the treatment period). | Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours) |
| Safety Endpoints | Incidence, severity and causality of adverse events and serious adverse events Overall skin tolerance (skin reactions evaluated by the dermatologist and the ones reported by the participants) after 28 days of the tested product use determined by Dermatologist | Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours) |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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