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

Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks With 1 Application Per Week (Maintenance Phase) on Subjects With Moderate to Severe Dandruff and Severe Itching State.

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

Study Overview

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

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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Mauritius
  • Phoenix, Mauritius, 73408
    • CIDP

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 and severe itching state in Phoenix 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 (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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28

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, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
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)	Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result)
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, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Standardized pictures of the scalp		Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
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, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28

Collaborators and Investigators

• Sponsor: Vichy Laboratoires
• Investigators: Principal Investigator: Gitanjali PETKAR, Dr, CIDP

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Actual): November 15, 2025
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 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; selenium disulfide
• Other Study ID Numbers: VCY 25-001

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