Atopic Dermatitis, Eczema
Conditions
Keywords
Eczema, Atopic Dermatisis, Body Cream
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 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.
Interventions
OTHERAnti-itching and repairing treatment. Emollient.
Anti-itching and repairing treatment. Emollient.
OTHEREmollient cream
Emollient cream
Sponsors
NAOS Les Laboratoires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Filling of a DLQI questionnaires by participants | Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours) | 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. |
| SCORAD (SCOring Atopic Dermatisis) | Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours) | 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. |
| EASI (Eczema Area and Severity Index) | Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours) | 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. |
| Transepidermal water loss by Vapometer® | Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours) | Transepidermal water loss by Vapometer® (on a defined AD lesion and on non-lesional area to the forearm)) |
| Samplings of the cutaneous microbiota | Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours) | 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. |
| Sleep quality by questionnaire (Pittsburgh Sleep Quality Index) filled in by participants | Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours) | 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. |
| Safety Endpoints | Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours) | 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 |
Countries
Georgia
Contacts
Primary ContactLela BERIDZE
Outcome results
None listed