Seborrheic DermatitisNCT07576023
A 4-weeks Comparative Study of Cosmetic Product Versus Standard Medical Care in Subjects With Seborrheic Dermatitis
A study testing RV5263A - WS0060, RV5263A - LC3302 and Standard Medical Care (SMC) in people with Seborrheic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
Trial summary
The aim of this study is to evaluate, with clinical and biological assessment methods, the effectiveness of the tested cosmetic product applied during 4 weeks of intensive treatment and compared to a Standard Medical Care (medicine shampoo) and to a comparative cosmetic shampoo, on mild to moderate recurrent squamous… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- RV5263A - WS0060, RV5263A - LC3302 and Standard Medical Care (SMC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 4 Feb 2025to 17 Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female aged between 18 and 70 years included
- Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable
- Subject having a squamous state of the scalp:
- clinically visible (Squire score ≥ 20),
- recurrent (at least twice a year)
- having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
Show all 18Show fewer
- Subject having a recent prescription of Standard Medical Care (Ketoconazole 2%) not yet initiated
- Subject accepting that according to the randomization, the Standard Medical Care can be possibly replaced by another shampoo, including neutral shampoo
- Subject having a maximum usual shampoo frequency of 3/week
- Non Inclusion criteria
- Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
- Subject having any other dermatologic condition than the studied squamous state on hair/ scalp and liable to interfere with the study assessments:
- alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis)
- raised skin lesion, likely to be traumatized, …
- Subject having dermatological pathology or evolutive skin lesion on the scalp (contact dermatitis, psoriasis, severe excoriations, severe sunburn, cutaneous bacterial superinfection of the scalp clinically obvious ...)
- Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
- Any scalp dyeing (including henna), bleaching, perm, smoothing / straightening performed within 3 weeks before inclusion or planned during the study
- Any topical hair product (conditioner, serum, mask, gel, lacquer, wax, foam…) or water applied on the scalp between the last shampoo and the inclusion visit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparative Study to Evaluate the Efficacy of the Shampoo RV5263A - WS0060 Applied for 4 Weeks in Adults Subjects With Recurrent Squamous States of Seborrheic Dermatitis in Comparison to Standard Medical Care and a Cosmetic Shampoo
The aim of this study is to evaluate, with clinical and biological assessment methods, the effectiveness of the tested cosmetic product applied during 4 weeks of intensive treatment and compared to a Standard Medical Care (medicine shampoo) and to a comparative cosmetic shampoo, on mild to moderate recurrent squamous states of seborrheic dermatitis.
Read the detailed description
This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.
A total number of 90 subjects included and randomized in 3 parallel groups:
- Test group RV5263A - WS0060 cosmetic product
- Comparative group: RV5263A - LC3302 cosmetic product
- Standard medical care group 6 visits are planned:
- Visit 1: Inclusion (Day 1)
- Visit 2: Intermediate visit (Day 4)
- Visit 3: Intermediate visit (Day 7)
- Visit 4: Intermediate visit (Day 15 ± 1 day)
- Visit 5: Intermediate visit (Day 22 ± 3 days)
- Visit 6: End-of-study visit (Day 29 ± 3 days)
- Conditions
- Seborrheic Dermatitis
- Being tested
- RV5263A - WS0060, RV5263A - LC3302, Standard Medical Care (SMC)
- Keywords
- seborrheic dermatitis, shampoo, squamous states, squire score, biological, samples, standard medical care, cosmetic product
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV5263A - WS0060Other
Cosmetic product Thrice weekly applications
RV5263A - LC3302Other
Cosmetic product Thrice weekly applications
Standard Medical Care (SMC)Drug
Standard medical care applications
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: RV5263A - WS0060 |
| Comparative group | Other | Not described Receives: Other: RV5263A - LC3302 |
| Standard medical care group | Active comparator | Not described Receives: Drug: Standard Medical Care (SMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dandruff severity (Squire score) after 29 days of product application
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
Measured: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).
Secondary outcomes (20)
Dandruff severity (Squire score) after 4, 7, 15 and 22 days of product application
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), and Visit 5 (Day 22)
Intensity of squamous global state
Intensity of the squamous state on a 4-point scale (from 0 to 3), performed by the investigator
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Irritation state score (erythema)
Erythema score on a 4-point scale (from 0 to 3), performed by the investigator
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Irritation state score (pruritus)
Mean pruritus felt on the last 3 days on a NRS (0-10), performed by the subject
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Irritation state score (burning sensation)
Burning sensation score, on a NRS (0-10), performed by the subject
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Immediate irritation state score (pruritus)
Immediate pruritus felt, on a NRS (0-10), performed by the subject
Measured: Immediately after the 1st application of product
Immediate irritation state score (burning sensation)
Immediate burning sensation score, on a NRS (0-10), performed by the subject
Measured: Immediately after the 1st application of product
Investigator Global Assessment
Investigator Global Assessment, on a 5-point scale (from 1 to 5), performed by the investigator
Measured: Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Subject Global Assessment
Subject Global Assessment, on a 5-point scale (from 1 to 5), performed by the subject
Measured: Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Evolution of squamous state (dandruff)
Squamous state (dandruff) score, on a 4-point scale, (from 0 to 3), performed by the subject
Measured: Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Evolution of discomfort
Discomfort evolution, on a 4-point scale (from 0 to 3), performed by the subject
Measured: Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Quality of Life, specific scalp questionnaire
Scalpdex questionnaire, completed by the subject
Measured: Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
Quality of life, Chronic Itch Burden scale
Chronic Itch Burden questionnaire, completed by the subject
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Acceptability Questionnaire assessment
Acceptability questionnaire regarding the use of the product will be completed by the subject.
Measured: Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
Recording of adverse events
Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
Measured: From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination)
Illustration of subject's squamous state evolution
Standardized photographs of the subject's scalp of affected area for illustrative purpose only
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Strains of the scalp microbiota
Via cotton-swab sampling
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
Scalp proteic markers
via cotton-swab sampling
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
Molecular characterization of the scalp sebum
via cigarette paper sampling
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Molecular characterization of the scalp - lipids
via cigarette paper sampling
Measured: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start4 Feb 2025
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT07576023
- Sponsor's protocol ID
- RV5263A20240639
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study to Evaluate the Efficacy of the Shampoo RV5263A - WS0060 Applied for 4 Weeks in Adults Subjects With Recurrent Squamous States of Seborrheic Dermatitis in Comparison to Standard Medical Care and a Cosmetic Shampoo
- ClinicalTrials.gov ID
- NCT07576023
- Acronym / sponsor ID
- RV5263A20240639
- Conditions
- Seborrheic Dermatitis
- Keywords
- seborrheic dermatitis, shampoo, squamous states, squire score, biological, samples, standard medical care, cosmetic product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 8 May 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, with clinical and biological assessment methods, the effectiveness of the tested cosmetic product applied during 4 weeks of intensive treatment and compared to a Standard Medical Care (medicine shampoo) and to a comparative cosmetic shampoo, on mild to moderate recurrent squamous states of seborrheic dermatitis.
Detailed description
This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.
A total number of 90 subjects included and randomized in 3 parallel groups:
- Test group RV5263A - WS0060 cosmetic product
- Comparative group: RV5263A - LC3302 cosmetic product
- Standard medical care group 6 visits are planned:
- Visit 1: Inclusion (Day 1)
- Visit 2: Intermediate visit (Day 4)
- Visit 3: Intermediate visit (Day 7)
- Visit 4: Intermediate visit (Day 15 ± 1 day)
- Visit 5: Intermediate visit (Day 22 ± 3 days)
- Visit 6: End-of-study visit (Day 29 ± 3 days)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: RV5263A - WS0060 |
| Comparative group | Other | Other: RV5263A - LC3302 |
| Standard medical care group | Active comparator | Drug: Standard Medical Care (SMC) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or Female aged between 18 and 70 years included
- Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable
- Subject having a squamous state of the scalp:
- Subject having a recent prescription of Standard Medical Care (Ketoconazole 2%) not yet initiated
- Subject accepting that according to the randomization, the Standard Medical Care can be possibly replaced by another shampoo, including neutral shampoo
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 |
|---|---|---|
| RV5263A - WS0060Cosmetic product Thrice weekly applications | Other | Test group |
| RV5263A - LC3302Cosmetic product Thrice weekly applications | Other | Comparative group |
| Standard Medical Care (SMC)Standard medical care applications | Drug | Standard medical care group |
Primary outcome
Dandruff severity (Squire score) after 29 days of product application
Time frame: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
20 secondary outcomes
Dandruff severity (Squire score) after 4, 7, 15 and 22 days of product application
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), and Visit 5 (Day 22)
Intensity of squamous global state
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Irritation state score (erythema)
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Irritation state score (pruritus)
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Irritation state score (burning sensation)
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Immediate irritation state score (pruritus)
Time frame: Immediately after the 1st application of product
Immediate irritation state score (burning sensation)
Time frame: Immediately after the 1st application of product
Investigator Global Assessment
Time frame: Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Subject Global Assessment
Time frame: Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Evolution of squamous state (dandruff)
Time frame: Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Evolution of discomfort
Time frame: Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Quality of Life, specific scalp questionnaire
Time frame: Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
Quality of life, Chronic Itch Burden scale
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Acceptability Questionnaire assessment
Time frame: Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
Recording of adverse events
Time frame: From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination)
Illustration of subject's squamous state evolution
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Strains of the scalp microbiota
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
Scalp proteic markers
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
Molecular characterization of the scalp sebum
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
Molecular characterization of the scalp - lipids
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination)
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 8 May 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 RV5263A - WS0060, RV5263A - LC3302 and Standard Medical Care (SMC) in people with Seborrheic 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?
The sponsor lists 18 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 8 May 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 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?
Dandruff severity (Squire score) after 29 days of product application (time frame: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).). 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 8 May 2026.