DandruffNCT07292467
Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks
An observational study of Dandruff, run by Vichy Laboratoires at 1 site in Mauritius.
Trial summary
The goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dandruff
- What is being tested?
- Selenium disulfide
- How many people
- 40 participants
- Where
- 1 siteMauritius
- Study dates
- 19 Mar 2025to 30 Jan 2026
- How long will I take part?
- 30 Weeks
- 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: Patients with moderate to severe dandruff and severe itching state in Phoenix in Mauritius
Who may be able to join
- At baseline: A moderate to severe level of squames: Total squames score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squames score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squames score at inclusion (The groups must be balanced to ensure an equitable distribution)
- All types of scalp.
- Any phototype
- Questionnaire inclusion: Food habits and sleep (at least 30 vols per item, a subject can be included in both groups)
- Severe itching score ≥ 7
- Subject with hair length > 2 cm.
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- Subject having received the information about the study modalities and having given his/her written consent and having signed the "informed consent form" specific for this study, in accordance with the corresponding procedure.
- Subject usually using a shampoo 3 times a week and accepting to follow a rate of 3 times a week during the whole study period.
- Subject agreeing not to use any other hair product other than the ones provided for the study (till the end of study); in particular:
- no styling product (tonic, spray, lotion, foam) three days before the study visit.
- no treating haircare product (conditioner, hair mask, non-rinsed hair care product, oil….).
- no anti-scales products (whatever the type: shampoo, treatment...).
- no hair coloring or hair bleaching within one week prior to any study visit.
- Subject agreeing not to have a short haircut during the entire study period.
- Subjects in good general and mental health in the opinion of the investigator
- Subjects demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form
- Subjects who have agreed to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
Who cannot join
- Subject with scalp psoriasis
- Subject with more than 60% of white hair influencing the scoring of scales.
- Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
- Subject with alopecia in vertex (stage > IIIa Hamilton and > I Ludwig)
- Subject who has used topic treatment for the scalp (anti-hair loss, soothing…) during the last three weeks before the start of the study.
- Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study.
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- Subject with history of allergy and/or reactions to latex.
- Subject who has taken:
- Corticoids (local or per os) within 2 weeks before the study entry
- Anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive orlithium-based drugs less than 1 month before the study entry,
- retinoid acid (local or per os) since less than 6 months before study entry.
- Subject practicing regularly water sport and/or having regular sauna sessions.
- Subject exposed to the sun or UV rays in an excessive way during the last month (according to the investigator).
- Pregnancy, breastfeeding, childbearing potential without adequate contraception, or irregular menstrual cycles.
- History of drug or alcohol abuse
- History or suspicion of unreliability, poor cooperation or noncompliance with medical treatment
- Topical treatment of the scalp with other antifungal medication or with corticosteroids in the last 3 weeks before the start of the study.
- Systemic use of erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study
- Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
- Clinical signs and/or history of immunosuppression
- Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris pectoris)
- Treatment with any other investigational drug in the 4 weeks prior to study entry
- Employee of the sponsor or the study site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks With 1 Application Per Week (Maintenance Phase) on Subjects With Moderate to Severe Dandruff and Severe Itching State.
The goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state.
Participants will:
Apply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products
Read the detailed description
=> after 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase)
Primary objective :
- To evaluate the reduction of total dandruff ( adherent and non-adherent)
Secondary objectives:
- To evaluate the Quality of Life (QoL) evolution
- To evaluate the reduction of discomfort (itching, stinging, burning sensation)
- To evaluate the reduction of scales
- To assess the cosmetic properties of investigational product
- To assess the tolerance of investigational product
- Conditions
- Dandruff
- Being tested
- Selenium disulfide
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium disulfideOther
1% SeS2
| Study group | Role | What they receive |
|---|---|---|
| Shampoo | Not described Receives: Other: Selenium disulfide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dandruff evaluation (non adherent and adherent)
Total score of dandruff = score of adherent and non adherent dandruff, which are 2 scales from 0 to 5 "0 is equivalent to no dandruff and 5 indicates a very large quantity of dandruff.
Measured: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Secondary outcomes (5)
Self-evaluation by subject of discomfort sensation (stinging, itching, burning sensation) on structured scale;
Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)
Measured: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Self-evaluation by subject of dandruff state and greasy aspect on structured scale
Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)
Measured: Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)
Quality of life questionnaire - Scalpdex
Publish questionnaire of quality of life, each item is evaluate with a 5-point scale from 0 (never, positive result) to 100 (always, negative result)
Measured: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Standardized pictures of the scalp
Measured: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Efficacy and cutaneaous acceptability
Questionnaire with 5 proposition for each question: completely agree, somewhat agree, neitheir agree or disagree, somewhat disagree, completely disagree
Measured: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start19 Mar 2025
- Primary completion15 Nov 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DandruffStudies 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
- 40 participants (actual)
- Target duration
- 30 Weeks
Sponsor and investigators
- Lead sponsor
- Vichy Laboratoires
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gitanjali PETKAR, Dr, Principal investigator, CIDP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292467
- Sponsor's protocol ID
- VCY 25-001
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks With 1 Application Per Week (Maintenance Phase) on Subjects With Moderate to Severe Dandruff and Severe Itching State.
- ClinicalTrials.gov ID
- NCT07292467
- Acronym / sponsor ID
- VCY 25-001
- Conditions
- Dandruff
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vichy LaboratoiresIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 18 Dec 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 goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state.
Participants will:
Apply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products
Detailed description
=> after 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase)
Primary objective :
- To evaluate the reduction of total dandruff ( adherent and non-adherent)
Secondary objectives:
- To evaluate the Quality of Life (QoL) evolution
- To evaluate the reduction of discomfort (itching, stinging, burning sensation)
- To evaluate the reduction of scales
- To assess the cosmetic properties of investigational product
- To assess the tolerance of investigational product
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shampoo | – | Other: Selenium disulfide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe dandruff and severe itching state in Phoenix in Mauritius
Key inclusion criteria (17 listed)
- At baseline: A moderate to severe level of squames: Total squames score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squames score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squames score at inclusion (The groups must be balanced to ensure an equitable distribution)
- All types of scalp.
- Any phototype
- Questionnaire inclusion: Food habits and sleep (at least 30 vols per item, a subject can be included in both groups)
- Severe itching score ≥ 7
Key exclusion criteria (24 listed)
- Subject with scalp psoriasis
- Subject with more than 60% of white hair influencing the scoring of scales.
- Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
- Subject with alopecia in vertex (stage > IIIa Hamilton and > I Ludwig)
- Subject who has used topic treatment for the scalp (anti-hair loss, soothing…) during the last three weeks before the start of the study.
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 |
|---|---|---|
| Selenium disulfide1% SeS2 | Other | Shampoo |
Primary outcome
Dandruff evaluation (non adherent and adherent)
Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Total score of dandruff = score of adherent and non adherent dandruff, which are 2 scales from 0 to 5 "0 is equivalent to no dandruff and 5 indicates a very large quantity of dandruff.
5 secondary outcomes
Self-evaluation by subject of discomfort sensation (stinging, itching, burning sensation) on structured scale;
Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Self-evaluation by subject of dandruff state and greasy aspect on structured scale
Time frame: Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)
Quality of life questionnaire - Scalpdex
Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Standardized pictures of the scalp
Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Efficacy and cutaneaous acceptability
Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
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 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Gitanjali PETKAR, Dr principal investigator
CIDP
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 Dandruff, run by Vichy Laboratoires at 1 site in Mauritius.
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 17 inclusion and 24 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 4 Mar 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 Mauritius. 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 evaluation (non adherent and adherent) (time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28). 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 4 Mar 2026.