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

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

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

Study Overview

• Status: Completed
• Conditions: Dandruff
• Intervention / Treatment: Other: Selenium disulfide; Other: Piroctone olamine

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Mauritius
  • Quatre Bornes, Mauritius
    • Eurofins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe dandruff in Quatre-Borne in Mauritius

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Routine Dercos; Shampoo + conditionner	Other: Selenium disulfide; 1% SeS2; Other: Piroctone olamine; 0.5% piroctone olamine
Shampoo alone Dercos; Shampoo	Other: Selenium disulfide; 1% SeS2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16
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)	Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16
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)	Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16
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	Questionnaire with 5 proposition for each question: completely agree, somewhat agree, neitheir agree or disagree, somewhat disagree, completely disagree	Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

Collaborators and Investigators

• Sponsor: Vichy Laboratoires
• Collaborators: Eurofins
• Investigators: Principal Investigator: Ashlam DOARIKA, Dr

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: August 13, 2025
• First Posted (Actual): August 21, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Scalp Dermatoses; Skin and Connective Tissue Diseases; Dandruff; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Trace Elements; Micronutrients; Antioxidants; Protective Agents; selenium disulfide; piroctone olamine
• Other Study ID Numbers: VCY 24-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No