Actively Recruiting

Phase Not Applicable
Age: 3Months - 12Years
All Genders
ID06756438

Evaluation of a Dermocosmetic Product Versus Placebo for Atopic Dermatitis in Children A Randomized, Double-Blind Study Under Dermatological Supervision

Led by NAOS Les Laboratoires · Updated on 2025-01-06

88

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Atopic eczema is a chronic inflammatory skin condition mainly affecting children, marked by itching and flare-ups. This study evaluates the effectiveness of a dermocosmetic product compared to a placebo in managing atopic skin, focusing on reducing the number, timing, and severity of eczema recurrences. The study also looks at symptoms including dryness, itching, and sleep quality, while monitoring skin acceptability of the treatments. Participants are randomly assigned to receive either the study product, which is an anti-itching, anti-relapse, and repairing emollient treatment, or a placebo emollient. These products are applied under dermatological supervision, alongside the participants' ongoing topical corticosteroid treatments. The study is conducted as a multicenter, double-blind clinical trial. During the study, eczema severity is measured using the SCORAD score at baseline (Day -X), Day 0, and at 2, 4, and 6 months after starting treatment. Dermatologists examine participants' skin on these same days to assess skin acceptability and monitor symptoms like dryness, itching, and sleep disturbances. Quality of life, sleep quality, and safety are also evaluated throughout the trial, which includes children aged 3 months to 12 years.

CONDITIONS

Official Title

Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.

Who Can Participate

Age: 3Months - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Female or male children
  • Age from 3 months up to 12 years old
  • Skin phototype I to IV
  • Atopic skin
  • Sensitive skin
  • At least 3 eczema flare-ups in the last 6 months including current flare-up
  • Currently experiencing an eczema flare-up treated with topical corticosteroids prescribed by a dermatologist
  • SCORAD score between 15 and 40 at baseline visit
  • No longer requiring medical treatment after corticosteroid use and resolved clinical signs by Day 0
  • Generally healthy
  • Parent or legal guardian has given informed consent
  • Parent or legal guardian willing to follow study procedures
  • Polish citizenship
Not Eligible

You will not qualify if you...

  • Skin disease in the study area other than atopic dermatitis
  • Use of treatments in the past weeks that may affect study results except prescribed corticosteroids
  • Surgery under general anesthesia within the previous month
  • Excessive sunlight or UV exposure within the previous month
  • Participation in another clinical trial affecting the study zones
  • Presence of oozing eczema lesions or signs of infection such as pus on eczema

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

EUROFINS

Gdansk, Poméranie, Poland, 82-210

Actively Recruiting

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Research Team

W

Wioleta MALINOWWSKA-KAKOL

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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