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NCT Number: NCT06930365

Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ltd Health

Batumi, Adjara, 6000, Georgia

Location status: Recruiting

Location contact

Lela BERIDZE

CONTACT

[email protected]

(+995) 59140 90 90

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-itching and repairing treatment. Emollient.

Other

Anti-itching and repairing treatment. Emollient.

emollient cream

Other

Emollient cream

Primary outcomes

  1. SCORAD (SCOring Atopic Dermatisis)

    Time frame: 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.

  2. EASI (Eczema Area and Severity Index)

    Time frame: 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.

  3. Transepidermal water loss by Vapometer®

    Time frame: 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))

  4. Samplings of the cutaneous microbiota

    Time frame: 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.

  5. Filling of a DLQI questionnaires by participants

    Time frame: 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.

  6. Sleep quality by questionnaire (Pittsburgh Sleep Quality Index) filled in by participants

    Time frame: 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.

  7. Safety Endpoints

    Time frame: 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

  8. Safety Endpoints

    Time frame: 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

    Tolerance feedback by participants by Daily log (filled in by participants during the treatment period).

  9. Safety Endpoints

    Time frame: 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lela BERIDZE

CONTACT

[email protected]

(+995) 59140 90 90

Sponsors and collaborators

Lead sponsor

NAOS Les Laboratoires

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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