ClinicalTrials.gg
CompletedNCT07133334Updated Mar 4, 2026

Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks Treatment and 12 Weeks Remanence

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
80
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this study is to to evaluate and compare the efficacy of the routine "Shampoo + Conditioner " versus " Shampoo alone" immediately after application and after 1 week, 2 weeks, 3 weeks, 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks and 12 weeks after applications stop (remanence phase) on subjects with moderate to severe dandruff.

Participants will:

Apply investigationnal products 3 time a week during 4 weeks and neutral or investigational products 3 time a week during 12 weeks Visit the center 9 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

Secondary objectives:

  • To evaluate and compare the Quality of Life (QoL) evolution of the routine " Shampoo and Conditioner " versus " Shampoo " alone, immediately after application and after 1, 2, 3, 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks and 12 weeks after applications stop (remanence phase);
  • To assess and compare the cosmetic properties of routine " Shampoo and Conditioner " versus " Shampoo " alone, immediately after application and after 1, 2, 3 and 4 weeks of use (treatment phase);
  • To assess the tolerance of routine " Shampoo and Conditioner " versus " Shampoo " alone, during 4 weeks of use.
02

Conditions studied

  • Dandruff
03

In context

Lead sponsor

Vichy Laboratoires is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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 in Quatre-Borne in Mauritius

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (groups must be equilibrating);
  • Patient with hair length > 2 cm;
  • Patient having received the information about the study modalities and having given his/her written consent and having signed the " form" specific for this study, in accordance with the corresponding procedure;
  • Patient usually using a shampoo 2 to 3 times a week and accepting to follow this rate during the whole study period;
  • Patient having stopped any possible soothing, anti-dandruff and anti-hair loss treatment (per os or topical) 2 weeks prior to study beginning D-14;
  • Patient 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 colouring or hair bleaching within one week prior to any study visit.

Exclusion criteria

Exclusion Criteria:

  • Subject with psoriasis;
  • Pregnancy, breast feeding, without adequate , 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 in the last 3 weeks before start of the study;
  • Systemic use of retinoids, erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study.
  • Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol;
  • Clinical signs and/or history of ;
  • Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris);
  • Treatment with any other drug in the 4 weeks prior to study entry.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

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

Groups and cohorts

  • Routine Dercos

    Shampoo + conditionner

    Other: Selenium disulfide · Other: Piroctone olamine

  • Shampoo alone Dercos

    Shampoo

    Other: Selenium disulfide

Interventions

  • OtherSelenium disulfide

    1% SeS2

  • OtherPiroctone olamine

    0.5% piroctone olamine

06

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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

  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: Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

  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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

  4. Standardized pictures of the scalp

    Time frame: Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

  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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

07

Study locations

1 site
  • Eurofins
    Quatre Bornes, Mauritius
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2025 to primary completion in Aug 2025, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2025
First posted
Aug 21, 2025
StartActual
Apr 2, 2025
Primary completionActual
Aug 18, 2025
CompletionActual
Sep 30, 2025
Last update
Mar 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07133334
Lead sponsor
Vichy Laboratoires
Collaborators
Eurofins
Responsible party
Sponsor
First posted
Aug 21, 2025
Start date
Apr 2, 2025
Primary completion
Aug 18, 2025
Completion
Sep 30, 2025
Last update
Mar 4, 2026

Study contacts

Ashlam DOARIKA, Dr
principal investigator

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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