Atopic DermatitisNCT06930365
Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis
A study testing Anti-itching and repairing treatment. Emollient. and Emollient cream in people with Atopic Dermatitis and Eczema, run by NAOS Les Laboratoires at 1 site in Georgia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Anti-itching and repairing treatment. Emollient. and Emollient cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGeorgia
- Study dates
- 9 Dec 2024to 18 Jul 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products (Investigational Product Versus Placebo) 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.
Read more
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.
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Anti-itching and repairing treatment. Emollient., Emollient cream
- Keywords
- Eczema, Atopic Dermatisis, Body Cream
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-itching and repairing treatment. Emollient.Other
Anti-itching and repairing treatment. Emollient.
Emollient creamOther
Emollient cream
| Study group | Role | What they receive |
|---|---|---|
| Amr 1: New Emollient | Experimental | Study product, Emollient. Face and body Receives: Other: Anti-itching and repairing treatment. Emollient. |
| Arm 2: Placebo | Placebo comparator | Product 2: Placebo, Emollient. face and body Receives: Other: Emollient cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD (SCOring Atopic Dermatisis)
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.
Measured: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)
EASI (Eczema Area and Severity Index)
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.
Measured: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)
Transepidermal water loss by Vapometer®
Transepidermal water loss by Vapometer® (on a defined AD lesion and on non-lesional area to the forearm))
Measured: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)
Samplings of the cutaneous microbiota
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.
Measured: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)
Filling of a DLQI questionnaires by participants
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.
Measured: 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
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.
Measured: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
Safety Endpoints
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
Measured: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
Safety Endpoints
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).
Measured: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
Safety Endpoints
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
Measured: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start9 Dec 2024
- Primary completion16 May 2025
- Study completion18 Jul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional , monocentric, double-blinded, randomized and comparative study. The study design is randomized: Enrolled participants will apply the new emollient versus placebo according to a previous defined randomization scheme.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- NAOS Les Laboratoires
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930365
- Sponsor's protocol ID
- RC2024/PSaib+/GE
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products (Investigational Product Versus Placebo) In Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06930365
- Acronym / sponsor ID
- RC2024/PSaib+/GE
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Eczema, Atopic Dermatisis, Body Cream
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- NAOS Les LaboratoiresIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 16 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Interventional , monocentric, double-blinded, randomized and comparative study. The study design is randomized: Enrolled participants will apply the new emollient versus placebo according to a previous defined randomization scheme.
| Arm | Type | Receives |
|---|---|---|
| Amr 1: New Emollient | Experimental | Other: Anti-itching and repairing treatment. Emollient.Study product, Emollient. Face and body |
| Arm 2: Placebo | Placebo comparator | Other: Emollient creamProduct 2: Placebo, Emollient. face and body |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| Anti-itching and repairing treatment. Emollient.Anti-itching and repairing treatment. Emollient. | Other | Amr 1: New Emollient |
| Emollient creamEmollient cream | Other | Arm 2: Placebo |
Primary outcome
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.
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.
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))
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.
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.
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.
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
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).
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
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 13 Oct 2026.
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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?
A study testing Anti-itching and repairing treatment. Emollient. and Emollient cream in people with Atopic Dermatitis and Eczema, run by NAOS Les Laboratoires at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. 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 13 Oct 2026. 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 Georgia. 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. Some participants in this study may receive a placebo. 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?
SCORAD (SCOring Atopic Dermatisis) (time frame: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.