Clinical trial NCT06930365: Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis
Official title: Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products (Investigational Product Versus Placebo) In Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Eczema
Keywords: Eczema
Atopic Dermatisis
Body Cream
Lead sponsor: NAOS Les Laboratoires
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: SCORAD (SCOring Atopic Dermatisis)
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)
measure: EASI (Eczema Area and Severity Index)
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)
measure: Transepidermal water loss by Vapometer®
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)
measure: Samplings of the cutaneous microbiota
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)
measure: Filling of a DLQI questionnaires by participants
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
measure: Sleep quality by questionnaire (Pittsburgh Sleep Quality Index) filled in by participants
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
measure: Safety Endpoints
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
measure: Safety Endpoints
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
measure: Safety Endpoints
timeFrame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Batumi
country: Georgia
facility: Ltd Health
state: Ajaria
Study officials:
References: