Evaluation of the Efficacy of a Dermocosmetic Product RT00401-GO0046 on Atopic Dermititis Severity in Subjects With Mild Atopic Dermatitis Versus Placebo

An observational study of Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to evaluate the RT00401- GO0046 formula on atopic dermititis severity in subjects with mild atopic dermatitis versus placebo on 26 subjects. The objectives of this study are: To evaluate the clinical efficacy of the RT00401-GO0046 cream compared to RT00401-GA0677 placebo cream on AD severity… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atopic Dermatitis
What is being tested?: RT00401-GO0046 and RT00401-GA0677
How many people: 32 participants
Where: 1 sitePoland
Study dates: 17 Feb 2025to 24 Jun 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. They will be definitely included in the study after a specific interview and a clinical examination.

Main Inclusion criteria :

Female and/or male;
Subject aged ≥ 18 years;
Subjects presenting atopic dermatitis according to the definition of "the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis";
Subject presenting a mild AD with a SCORAD from 15 to 20 with dryness evaluation parameter ≥ 2 at inclusion;
Based on the subject's statements regarding their skin condition history:
Subject with AD symmetric lesions, size from 10 to 15 cm² on both target areas;
Subject who will likely present a flare-up during their participation according to investigator's opinion;

Main Non inclusion criteria

Subject whose skin condition in the potential target areas is contact eczema or dyshidrotic eczema rather than atopic dermatitis (particularly on feet).
Subject having any other dermatologic condition than Atopic Dermatitis, or characteristics (like tattoo) on the tested areas, liable to interfere with the study assessments according to investigator opinion;
Subject having significant hair growth on tested areas;
Subject presenting a flare-up at time of inclusion visit requiring a therapeutic care;

Trial locations and contacts

1 site in 1 country.

Poland1 site

Dermscan Poland
Gdansk, Poland, 80288

Other trials in Poland

About this study

Official title: A Randomized, Comparative, Investigator-blinded Study to Evaluate the Efficacy of a Dermocosmetic Product RT00401 - Formula: GO0046 on Atopic Dermititis Severity in Subjects With Mild Atopic Dermatitis Versus Placebo.

The aim of this study is to evaluate the RT00401- GO0046 formula on atopic dermititis severity in subjects with mild atopic dermatitis versus placebo on 26 subjects.

The objectives of this study are:

To evaluate the clinical efficacy of the RT00401-GO0046 cream compared to RT00401-GA0677 placebo cream on AD severity of tested areas and flare-up onset.
To evaluate the effect of the RT00401-GO0046 cream on microbiota diversity and other pharmaco-clinical biomarkers with respective techniques on skin surface in subjects with AD compared to the effect of the RT00401-GA0677 placebo cream.
To illustrate the effect of the RT00401-GO0046 cream with photos of the tested areas.

This study will be conducted as an intra-individual, comparative, randomized, monocentric, investigator-blinded study, with 3 visits are planned:

Visit 1 (D1): Inclusion and 1st products application
Visit 2 (D29 +/- 2 days): 1-month follow-up visit
Visit X (Suspected flare-up +/- 2 days): End-of-study visit if AD flare-up is confirmed
Visit 3 (D85 +/- 3 days): End-of-study visit This clinical study is designed as an investigator-blinded study. Participants will be required to apply two different products, one on each side: Product A and Product B. One of these products is the "test product" RT00401 Formula GO0646, and the other is the "control product" RT00401 Formula GA0677. However, participants will not know which product is which. The randomization will determine the side on which each product is applied (Product A on the right and Product B on the left, or vice versa). The product tubes will be identical, ensuring that neither the participants nor the investigator will know which product is the test product or the control product. This blinding ensures that neither the participants nor the investigator will be influenced by the nature of the products applied, thereby enhancing the robustness and objectivity of the study results.

Conditions: Atopic Dermatitis
Being tested: RT00401-GO0046, RT00401-GA0677
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RT00401-GO0046Other
Cosmetic care product
RT00401-GA0677Other
Placebo cosmetic care product

Study groups in NCT06763939
Study group	Role	What they receive
Subjects with mild atopic dermatitis		This is an intra-individual study. The included subjects will apply both products, one on each side of target areas. The target areas can be located on both arms, both legs, both feet, both sides of lower back, or both sides of face (for women only) or lower back if the zones are clearly distinct and accessible for the products application. One of the identified areas will be tested with RT00401-GO0046 cream and the symmetric area will be tested with RT00401-GA0677 cream according to randomization. Not all study participants will apply the products to the same sides. Receives: Other: RT00401-GO0046; Other: RT00401-GA0677

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of SCORAD
an examination of the face and body of the subject is carried out by the dermatologist in charge of the study to evaluate the initial intensity of atopic dermatitis by determination of SCORAD index
Measured: At baseline (Day 1) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Evaluation of L-SCORAD
The Local SCORAD is the evaluation of the objective parameters of the SCORAD will be assessed independently on both target areas by the Investigator
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Evaluation of L-PO SCORAD
The Local PO SCORAD will be evaluated by the subjects independently on the same target areas that L-SCORAD
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Evolution of pruritus sensations using numerical rating scale (NRS)
The subject will realize auto-scoring of pruritus independently on both target areas perceived (with average intensity over the last 3 days) using a Numeric Rating Scale from 0 (no pruritus) to 10 (severe discomfort sensations).
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Microbiota diversity
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Metabolomic features
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Cytokine panel
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Transepidermal water loss measurments by tewameter®
A trans-epidermal water loss will be measured with a Tewameter TM 300® independently on both target areas
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Skin pH measurements by phmeter
A cutaneous pH level will be measured with a COURAGE \& KHAZAKA PH 900 PC Skin pHmeter® fitted with an Ingold® electrode independently on both target areas
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Investigator Global Assessment (IGA)
IGA will be assessed by the investigator independently on both target areas perceived at each study visit from Visit 2, compared to Visit 1, according to a 5-point scale: 0= worse, 1= no change, 2= slight improvement, 3= marked improvement; 4= total resolution Local IGA assesses the evolution of target areas AD basing on objective signs (erythema, oedema/papulation, oozing/crusts, excoriation, lichenification, dryness) compared to baseline (Visit 1).
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Patient Global Assessment (PGA)
PGA will be assessed by the subjects independently on both target areas perceived at each study visit from Visit 2, compared to Visit 1, according to a 5-point scale: 0= worse 1= no change, 2= slight improvement, 3= marked improvement; 4= total resolution Local PGA assesses the evolution of target areas AD intensity compared to baseline (Visit 1).
Measured: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
Atopic dermititis severity by counting of flare-up onset
At the end of the study, the number of flare-ups that occurred during the study will be evaluated
Measured: At the end of study, after last patient out, approximately 6 months after the beggining of the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 202524 Jun 2025

First posted8 Jan 2025
Study start17 Feb 2025
Primary completion24 Jun 2025
Study completion24 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06763939
Sponsor's protocol ID: RT0040120240799
Status last verified: Aug 2025
First submitted: 20 Dec 2024
Last updated: 28 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Comparative, Investigator-blinded Study to Evaluate the Efficacy of a Dermocosmetic Product RT00401 - Formula: GO0046 on Atopic Dermititis Severity in Subjects With Mild Atopic Dermatitis Versus Placebo.
ClinicalTrials.gov ID: NCT06763939
Acronym / sponsor ID: RT0040120240799
Conditions: Atopic Dermatitis
Study type: Observational
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
Study start: 17 Feb 2025 (actual)
Primary completion: 24 Jun 2025 (actual)
Study completion: 24 Jun 2025 (actual)
First posted: 8 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to evaluate the RT00401- GO0046 formula on atopic dermititis severity in subjects with mild atopic dermatitis versus placebo on 26 subjects.

The objectives of this study are:

To evaluate the clinical efficacy of the RT00401-GO0046 cream compared to RT00401-GA0677 placebo cream on AD severity of tested areas and flare-up onset.
To evaluate the effect of the RT00401-GO0046 cream on microbiota diversity and other pharmaco-clinical biomarkers with respective techniques on skin surface in subjects with AD compared to the effect of the RT00401-GA0677 placebo cream.
To illustrate the effect of the RT00401-GO0046 cream with photos of the tested areas.

This study will be conducted as an intra-individual, comparative, randomized, monocentric, investigator-blinded study, with 3 visits are planned:

Visit 1 (D1): Inclusion and 1st products application
Visit 2 (D29 +/- 2 days): 1-month follow-up visit
Visit X (Suspected flare-up +/- 2 days): End-of-study visit if AD flare-up is confirmed
Visit 3 (D85 +/- 3 days): End-of-study visit This clinical study is designed as an investigator-blinded study. Participants will be required to apply two different products, one on each side: Product A and Product B. One of these products is the "test product" RT00401 Formula GO0646, and the other is the "control product" RT00401 Formula GA0677. However, participants will not know which product is which. The randomization will determine the side on which each product is applied (Product A on the right and Product B on the left, or vice versa). The product tubes will be identical, ensuring that neither the participants nor the investigator will know which product is the test product or the control product. This blinding ensures that neither the participants nor the investigator will be influenced by the nature of the products applied, thereby enhancing the robustness and objectivity of the study results.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subjects with mild atopic dermatitis	–	Other: RT00401-GO0046, Other: RT00401-GA0677This is an intra-individual study. The included subjects will apply both products, one on each side of target areas. The target areas can be located on both arms, both legs, both feet, both sides of lower back, or both sides of face (for women only) or lower back if the zones are clearly distinct and accessible for the products application. One of the identified areas will be tested with RT00401-GO0046 cream and the symmetric area will be tested with RT00401-GA0677 cream according to randomization. Not all study participants will apply the products to the same sides.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. They will be definitely included in the study after a specific interview and a clinical examination.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RT00401-GO0046Cosmetic care product	Other	Subjects with mild atopic dermatitis
RT00401-GA0677Placebo cosmetic care product	Other	Subjects with mild atopic dermatitis

Primary outcome

Evaluation of SCORAD
Time frame: At baseline (Day 1) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
an examination of the face and body of the subject is carried out by the dermatologist in charge of the study to evaluate the initial intensity of atopic dermatitis by determination of SCORAD index
Evaluation of L-SCORAD
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
The Local SCORAD is the evaluation of the objective parameters of the SCORAD will be assessed independently on both target areas by the Investigator
Evaluation of L-PO SCORAD
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
The Local PO SCORAD will be evaluated by the subjects independently on the same target areas that L-SCORAD
Evolution of pruritus sensations using numerical rating scale (NRS)
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
The subject will realize auto-scoring of pruritus independently on both target areas perceived (with average intensity over the last 3 days) using a Numeric Rating Scale from 0 (no pruritus) to 10 (severe discomfort sensations).
Microbiota diversity
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Metabolomic features
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Cytokine panel
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses
Transepidermal water loss measurments by tewameter®
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A trans-epidermal water loss will be measured with a Tewameter TM 300® independently on both target areas
Skin pH measurements by phmeter
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
A cutaneous pH level will be measured with a COURAGE \& KHAZAKA PH 900 PC Skin pHmeter® fitted with an Ingold® electrode independently on both target areas
Investigator Global Assessment (IGA)
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
IGA will be assessed by the investigator independently on both target areas perceived at each study visit from Visit 2, compared to Visit 1, according to a 5-point scale: 0= worse, 1= no change, 2= slight improvement, 3= marked improvement; 4= total resolution Local IGA assesses the evolution of target areas AD basing on objective signs (erythema, oedema/papulation, oozing/crusts, excoriation, lichenification, dryness) compared to baseline (Visit 1).
Patient Global Assessment (PGA)
Time frame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
PGA will be assessed by the subjects independently on both target areas perceived at each study visit from Visit 2, compared to Visit 1, according to a 5-point scale: 0= worse 1= no change, 2= slight improvement, 3= marked improvement; 4= total resolution Local PGA assesses the evolution of target areas AD intensity compared to baseline (Visit 1).
Atopic dermititis severity by counting of flare-up onset
Time frame: At the end of study, after last patient out, approximately 6 months after the beggining of the study.
At the end of the study, the number of flare-ups that occurred during the study will be evaluated

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of SCORAD (time frame: At baseline (Day 1) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06763939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.