ClinicalTrials.gg
CompletedNCT07577921Updated May 11, 2026

Evaluation of the Efficacy of a Cosmetic Care in Subjects With Moderate to Severe Atopic Dermatitis, Treated by Systemic Treatments

An observational study in Atopic Dermatitis, sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Atopic dermatitis (AD) is a common chronic inflammatory skin disease, affecting both children (15- 20%) and adults (2-5%). The pathogenesis of AD is complex and multifactorial, including skin barrier dysfunction and immune dysregulation.

AD often requires a long management and has a major impact on quality of life. For mild to moderate disease, first-line treatment involves topical therapies including corticosteroids and calcineurin inhibitors. Patients with more severe and refractory symptoms require systemic treatments as phototherapy, conventional systemic treatments (cyclosporine, methotrexate…), biologics and JAK-inhibitors.

Regardless of the severity of the disease, additional basic topical treatment with emollient is the mainstay of the management. Emollients, commonly referred to as moisturizing creams are well known for their role in moisture retention, barrier repair and symptom control in AD.

Publications on emollient in atopic dermatitis are numerous but there are limited data on how patients with AD treated by systemic treatment use and evaluate emollients.

The aims of this study are to evaluate the efficacy of the cosmetic care product RV4427C WM0071 in subjects suffering from moderate to severe AD, treated and controlled by systemic treatments by assessing the cosmetic satisfaction, perceived effects and habits of use as regards to the use of the cosmetic care product RV4427C WM0071, and to qualify this population of subjects in terms of pathology, the state of their skin at this stage of their systemic treatment (controlled period), their habits, needs and expectations regarding the use of emollient.

This study will be conducted as an exploratory, proof of concept study in adult subjects suffering from moderate to severe AD, treated and controlled by systemic treatments.

3 visits are planned:

  • Visit 1 (Day 1): Inclusion
  • Visit 2 (from Day 2 to Day 8): Intermediate visit - remote visit for subject's questionnaire filling
  • Visit 3 (Visit 2 + 28 days +/- 2 days): End-of-study visit - remote visit for subject's questionnaire filling
02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's enrollment of 80 is below the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Pierre Fabre Dermo Cosmetique is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will be enrolled from the investigator's outpatients reception and/or from the database of the centre.

The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.

Eligibility criteria

Inclusion Criteria:

Criteria related to the population:

  • Subject aged between 18 and 75 years included
  • Subject having signed his/her written for his/her participation in the study
  • Subject affiliated to a social security system or health insurance, or is a beneficiary (if required by national regulations
  • Subject with appropriate hardware (smartphone and/or tablet and/or computer) to complete digital questionnaires
  • Subject with a mailbox and internet access to create his account to complete digital questionnaires

Criteria related to the disease and treatment:

  • Subject with moderate to severe AD controlled by systemic treatment, meaning:
  • Using systemic treatment for AD (biologics, janus kinase inhibitors or conventional ) initiated for at least 6 months at the time of the inclusion visit
  • With an unchanged systemic treatment dose for at least 2 months at the time of the inclusion visit,
  • And with an vIGA-ADTM ≤ 2 (Mild).

Non Inclusion criteria:

Criteria related to the population:

  • Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in writing in the questionnaire
  • For woman of : pregnant or breastfeeding or planning to be pregnant during the study
  • Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship
  • Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
  • Subject who is currently participating, who plans to participate or who has participated within the previous weeks or months in another clinical study liable to interfere with the study assessments according to the investigator's assessment
  • Subject who has already participated to ADNEEDS study
  • Subject is in a position likely to represent a conflict of interest and/or is a family member of any people involved in the conduct of the study (secretary, nurse, technician,…), of the site

Criteria related to the diseases / skin condition:

  • Subject with history of allergy or intolerance to any of the tested product ingredients
  • Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Subjects with atopic dermatitis

    Other: Investigational cosmetic product RV4427C

Interventions

  • OtherInvestigational cosmetic product RV4427C

    Product is applied at home by the subject between Visit 2 and Visit 3, 1 to 2 application(s) per day, on face and body, in replacement of the subject's usual product(s). For a subject completing the study, the theoretical product exposure will be 28 days. The maximal product exposure will be 30 days.

06

What researchers measure

Primary outcomes

  1. Epidemiological data

    By a questionnaire filled in by all subjects to characterize and describe the population in terms of pathology, state of the skin, habits, needs and expectations of patients regarding the use of emollient

    Time frame: Visit 2 (from Day 2 to Day 8)

  2. Efficacy of the cosmetic care product

    By questionnaires filled in by all subjects on cosmetic satisfaction, perceived effects and habits of use

    Time frame: Visit 2 (from Day 2 to Day 8) +5 days & Visit 3 (Visit 2 + 28 days +/- 2 days)

07

Study locations

1 site
  • Allergologie et Immunologie Clinique, CHU Lyon Sud
    Pierre-Bénite, F-69495, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2025 to primary completion in Apr 2026, 11 months.

Of 74 industry-sponsored observational studies under Dermatitis, Atopic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's 11 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2025
First posted
May 11, 2026
StartActual
May 12, 2025
Primary completionActual
Apr 17, 2026
CompletionActual
Apr 17, 2026
Last update
May 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07577921
Responsible party
Sponsor
First posted
May 11, 2026
Start date
May 12, 2025
Primary completion
Apr 17, 2026
Completion
Apr 17, 2026
Last update
May 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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