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CompletedNCT07292467Updated Mar 4, 2026

Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks

An observational study in Dandruff, sponsored by Vichy Laboratoires. Completed at 1 site in Mauritius. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by Vichy Laboratoires · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

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
02

Conditions studied

  • Dandruff
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with moderate to severe dandruff and severe itching state in Phoenix in Mauritius

Inclusion criteria

  • 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.
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Target follow-up
30 Weeks
Patient registry
Yes

Groups and cohorts

  • Shampoo

    Other: Selenium disulfide

Interventions

  • OtherSelenium disulfide

    1% SeS2

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28

Secondary outcomes

  1. 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)

    Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28

  2. 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)

    Time frame: Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)

  3. 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)

    Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28

  4. 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

  5. Efficacy and cutaneaous acceptability

    Questionnaire with 5 proposition for each question: completely agree, somewhat agree, neitheir agree or disagree, somewhat disagree, completely disagree

    Time frame: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28

06

Study locations

1 site
  • CIDP
    Phoenix, 73408, Mauritius
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07292467
Lead sponsor
Vichy Laboratoires
Responsible party
Sponsor
First posted
Dec 18, 2025
Start date
Mar 19, 2025
Primary completion
Nov 15, 2025
Completion
Jan 30, 2026
Last update
Mar 4, 2026

Study contacts

Gitanjali PETKAR, Dr
principal investigator · CIDP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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