Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis

Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products (Investigational Product Versus Placebo) In Atopic Dermatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Eczema; Atopic Dermatitis
• Intervention / Treatment: Other: Anti-itching and repairing treatment. Emollient.; Other: Emollient cream

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lela BERIDZE; Phone Number: (+995) 59140 90 90; Email: lelbe1@rambler.ru

Study Locations

• Georgia
  • Ajaria
    • Batumi, Ajaria, Georgia, 6000
      • Recruiting
      • LTD Health
      • Contact: Lela BERIDZE; Phone Number: (+995) 59140 90 90; Email: lelbe1@rambler.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 2: Placebo; Product 2: Placebo, Emollient. face and body	Other: Emollient cream; Emollient cream
Experimental: Amr 1: New Emollient; Study product, Emollient. Face and body	Other: Anti-itching and repairing treatment. Emollient.; Anti-itching and repairing treatment. Emollient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: NAOS Les Laboratoires

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): May 16, 2025
• Study Completion (Estimated): July 18, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Eczema; Atopic Dermatisis; Body Cream
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Dermatologic Agents; Emollients
• Other Study ID Numbers: RC2024/PSaib+/GE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No