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Recruiting NCT06930365

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

No phase Interventional Atopic Dermatitis Eczema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anti-itching and repairing treatment. Emollient., Emollient cream.
Who it may be relevant to
Registry conditions: Atopic Dermatitis, Eczema. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Georgia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Anti-itching and repairing treatment. Emollient.
    Anti-itching and repairing treatment. Emollient.
  • Other Emollient cream
    Emollient cream

Primary outcome measures

  • SCORAD (SCOring Atopic Dermatisis) [Time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)]
  • EASI (Eczema Area and Severity Index) [Time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)]
  • Transepidermal water loss by Vapometer® [Time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)]
  • Samplings of the cutaneous microbiota [Time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)]
  • Filling of a DLQI questionnaires by participants [Time frame: 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 [Time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]
  • Safety Endpoints [Time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]
  • Safety Endpoints [Time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]
  • Safety Endpoints [Time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Georgia · 1 center
  • Ltd Health — Batumi

Identifiers

NCT: NCT06930365 · RC2024/PSaib+/GE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗