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Completed

NCT Number: NCT07133334

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eurofins

Quatre Bornes, Mauritius

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 "informed consent 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

  • Subject with psoriasis;
  • Pregnancy, breast feeding, 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 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 immunosuppression;
  • Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris);
  • Treatment with any other investigational drug in the 4 weeks prior to study entry.

Treatment and study plan

Selenium disulfide

Other

1% SeS2

Piroctone olamine

Other

0.5% piroctone olamine

Primary outcomes

  1. Dandruff evaluation (non adherent and adherent)

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

    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.

Secondary outcomes

  1. Self-evaluation by subject of discomfort sensation (stinging, itching, burning sensation) on structured scale;

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

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

  2. Self-evaluation by subject of dandruff state and greasy aspect on structured scale

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

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

  3. Quality of life questionnaire - Scalpdex

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

    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)

  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

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

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

Sponsors and collaborators

Lead sponsor

Vichy Laboratoires

Industry

Collaborators

  • Eurofins

Registry information

Official study title

Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks of Treatment and 12 Weeks Remanence n Subjects With Moderate to Severe Dandruff

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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