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

NCT06930365 | Recruiting

• 1 other identifier: RC2024/PSaib+/GE
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Keywords

Eczema; Atopic Dermatisis; Body Cream

Outcome Measures

Primary Outcomes (9)

• 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)

Study Arms (2)

Amr 1: New Emollient

EXPERIMENTAL

Study product, Emollient. Face and body

Other: Anti-itching and repairing treatment. Emollient.

Arm 2: Placebo

PLACEBO COMPARATOR

Product 2: Placebo, Emollient. face and body

Other: Emollient cream

Interventions

Anti-itching and repairing treatment. Emollient. OTHER

Anti-itching and repairing treatment. Emollient.

Amr 1: New Emollient

Emollient cream OTHER

Emollient cream

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• subjects having a rash of eczema (SCORAD between 25 and 50) with at least 1 lesional area requiring topical corticosteroid treatment,
• healthy subjects (without any dermatological pathology nor disorder),
• 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.

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• NAOS Les Laboratoires: lead

Study Sites (1)

Ltd Health

Batumi, Adjara, 6000, Georgia

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Diphenhydramine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Lela BERIDZE

CONTACT

(+995) 59140 90 90; lelbe1@rambler.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: April 16, 2025
• Study Start: December 9, 2024
• Primary Completion: May 16, 2025
• Study Completion: July 18, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

GE (1)