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

NCT07133334 — Completed, 80 participants, Vichy Laboratoires

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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

RegistryNCT07133334
StatusCompleted
Study typeObservational
Enrollment80 (Actual)
SponsorVichy Laboratoires (Industry); collaborators: Eurofins
ConditionsDandruff
InterventionsSelenium disulfide, Piroctone olamine (Other)
Datesstart 2025-04-02, primary completion 2025-08-18, completion 2025-09-30, first posted 2025-08-21, last updated 2026-03-04
Locations1 site in Mauritius

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-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Routine DercosOther: Selenium disulfide; Other: Piroctone olamineShampoo + conditionner
Shampoo alone DercosOther: Selenium disulfideShampoo
  • Selenium disulfide (Other): 1% SeS2
  • Piroctone olamine (Other): 0.5% piroctone olamine

+Outcome measures

Primary outcomes

  • Dandruff evaluation (non adherent and adherent) [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

  • Self-evaluation by subject of discomfort sensation (stinging, itching, burning sensation) on structured scale; [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)
  • Self-evaluation by subject of dandruff state and greasy aspect on structured scale [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)
  • Quality of life questionnaire - Scalpdex [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)
  • Standardized pictures of the scalp [Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16]
  • Efficacy and cutaneaous acceptability [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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
EurofinsQuatre BornesMauritius

+Investigators

  • Ashlam DOARIKA, Dr, Principal investigator

My Notes