Atopic Dermatitis (AD)NCT07839897
EFFICACY AND TOLERANCE OF AN EMOLLIENT CREAM IN SKIN OF COLOR
A study testing Emollient cream RV4660B in people with Atopic Dermatitis (AD), run by Pierre Fabre Dermo Cosmetique at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the efficacy and tolerance of a face and body emollient cream in individuals (infants, children, adults) with phototypes IV-VI presenting mild to moderate atopic dermatitis (study under dermatological control) Read more about this study
- Who is it for?
- Ages 2 months to 45 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Emollient cream RV4660B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- 7 May 2025to 21 Aug 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 2 months to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female (no minimum required);
- Age as presented below:
- 18-45 years old (n=20)
- 2-17 years old (n=15)
- 28 days to 23 months (n=15)
- Phototypes IV-VI according to the Fitzpatrick scale following the distribution bellow:
Show all 12Show fewer
- Phototype IV: at least 2 by each age group
- Phototypes V and VI: at least 75% by each age group and at least 2 by phototype
- Subjects presenting atopic dermatitis according to the definition of "the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis";
- Presenting atopic dermatitis with a SCORAD from 15 to 30
- Subjects (18-45 years old) presenting at least one PIH and/or post inflammatory hypopigmentation induced by atopic dermatitis
- Subjects who used the same cleansing product on face and body, the same make-up (if applicable), the same sunscreen product for at least two weeks before inclusion and remain stable during the whole study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE EFFICACY AND TOLERANCE OF A FACE AND BODY EMOLLIENT CREAM IN SUBJECTS (INFANTS, CHILDREN, ADULTS) WITH MILD TO MODERATE ATOPIC DERMATITIS UNDER DERMATOLOGICAL CONTROL
The aim of this study is to evaluate the efficacy and tolerance of a face and body emollient cream in individuals (infants, children, adults) with phototypes IV-VI presenting mild to moderate atopic dermatitis (study under dermatological control)
Read the detailed description
This study is conducted as a single-center, open-labeled study in Latin America. A total of 59 subjects are enrolled in the study. Assessments are performed at Day 1, Day 8 and Day 29.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Emollient cream RV4660B
- Keywords
- Atopic Dermatitis, Cosmetic
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emollient cream RV4660BOther
Emollient cream, applied once daily to face and body for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Emollient treatment group | Experimental | All enrolled subjects (infants, children and adults) with atopic dermatitis and phototypes IV-VI (Fitzpatrick scale) receive the tested emollient cream applied once daily for 4 weeks. Receives: Other: Emollient cream RV4660B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis)
Evolution of the SCORAD assessed by the Investigator at each visit
Measured: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Secondary outcomes (9)
Atopic Dermatitis Severity by the investigator- L-SCORAD (Local SCORing Atopic Dermatitis)
Evolution of the Local-SCORAD assessed by the Investigator at each visit on a target area (= area most representative of Atopic Dermatitis severity of the entire body)
Measured: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Atopic Dermatitis Severity by the subject- PO-SCORAD (Patient-Oriented SCORing Atopic Dermatitis)
Evolution of the PO-SCORAD self-assessed by the subject or parent's)/legal representative at each visit
Measured: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Discomfort sensations
Evolution of discomfort self-assessed by the subject or parent's)/legal representative using a Numerical Rating Scale (NRS, 0-10; 0 = no symptom, 10 = worst imaginable symptom)
Measured: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Dermatological tolerance of the tested product
Tolerance assessed by the Investigator at each study visit. The results will take into account the clinical signs observed by the investigators and the signs reported by the subject based on a 5-point scale (From 1 = Excellent tolerance to 5 = Bad tolerance)
Measured: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Quality of life questionnaire
Quality of life self-assessed by the subject or parent's)/legal representative by completing the Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CDLQI) or Infant Dermatology Quality of Life Index (IDQOL) questionnaire according to the subject age
Measured: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Atopic dermatitis disease control
Atopic dermatitis disease control self-assessed by the subject or parent's)/legal representative by completing the ADCT (Atopic Dermatitis Control Tool) questionnaire. The outcome measure assesses AD control over the past week, including symptom frequency and impact on daily activities. Total score ranges from 0 to 24; a score ≥ 7 indicates inadequately controlled AD.
Measured: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Acceptability Questionnaire assessment
Acceptability questionnaire regarding the use of the product completed by the subject/legal representative.
Measured: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Post-Inflammatory Hyper- or Hypo-pigmentation Intensity on a Target Lesion
Evolution of one selected post inflammatory hyperpigmentation area AND/OR one selected post inflammatory hypopigmentation area induced by atopic dermatitis assessed by the dermatologist using a 4-point lesion intensity scale (0=none to 3=severe).
Measured: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Extent of Dyschromic Areas
Evolution of the extent of skin areas affected by post-inflammatory dyschromia (hyper- or hypopigmentation) assessed by the investigator using the SCORAD parameter A methodology (rule of nines, scale 0 to 100), adapted to dyschromic lesions.
Measured: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start7 May 2025
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839897
- Sponsor's protocol ID
- RV4660B20240932
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFICACY AND TOLERANCE OF A FACE AND BODY EMOLLIENT CREAM IN SUBJECTS (INFANTS, CHILDREN, ADULTS) WITH MILD TO MODERATE ATOPIC DERMATITIS UNDER DERMATOLOGICAL CONTROL
- ClinicalTrials.gov ID
- NCT07839897
- Acronym / sponsor ID
- RV4660B20240932
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis, Cosmetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 7 May 2025 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 24 Sep 2026 (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 efficacy and tolerance of a face and body emollient cream in individuals (infants, children, adults) with phototypes IV-VI presenting mild to moderate atopic dermatitis (study under dermatological control)
Detailed description
This study is conducted as a single-center, open-labeled study in Latin America. A total of 59 subjects are enrolled in the study. Assessments are performed at Day 1, Day 8 and Day 29.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emollient treatment group | Experimental | Other: Emollient cream RV4660BAll enrolled subjects (infants, children and adults) with atopic dermatitis and phototypes IV-VI (Fitzpatrick scale) receive the tested emollient cream applied once daily for 4 weeks. |
Who may qualify
- Ages
- 2 months to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Male or female (no minimum required);
- Age as presented below:
- Phototypes IV-VI according to the Fitzpatrick scale following the distribution bellow:
- Subjects presenting atopic dermatitis according to the definition of "the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis";
- Presenting atopic dermatitis with a SCORAD from 15 to 30
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Emollient cream RV4660BEmollient cream, applied once daily to face and body for a period of 4 weeks. | Other | Emollient treatment group |
Primary outcome
Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Evolution of the SCORAD assessed by the Investigator at each visit
9 secondary outcomes
Atopic Dermatitis Severity by the investigator- L-SCORAD (Local SCORing Atopic Dermatitis)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Atopic Dermatitis Severity by the subject- PO-SCORAD (Patient-Oriented SCORing Atopic Dermatitis)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Discomfort sensations
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Dermatological tolerance of the tested product
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Quality of life questionnaire
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Atopic dermatitis disease control
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Acceptability Questionnaire assessment
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Post-Inflammatory Hyper- or Hypo-pigmentation Intensity on a Target Lesion
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Extent of Dyschromic Areas
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
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 24 Sep 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 Emollient cream RV4660B in people with Atopic Dermatitis (AD), run by Pierre Fabre Dermo Cosmetique at 1 site in Brazil.
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 12 inclusion and 0 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 24 Sep 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 Brazil. 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?
Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis) (time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)). 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 24 Sep 2026.