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

NCT07292467 | Completed

• 1 other identifier: VCY 25-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dandruff

Outcome Measures

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.

  Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28

Secondary Outcomes (5)

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

  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)

• Quality of life questionnaire - Scalpdex

  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

  Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28

Study Arms (1)

Shampoo

Other: Selenium disulfide

Interventions

Selenium disulfide OTHER

1% SeS2

Shampoo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe dandruff and severe itching state in Phoenix in Mauritius

You may qualify if:

• All types of scalp.
• Any phototype
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vichy Laboratoires: lead

Study Sites (1)

CIDP

Phoenix, 73408, Mauritius

Location

MeSH Terms

Conditions

Dandruff

Interventions

selenium disulfide

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Scalp Dermatoses

Study Officials

• Gitanjali PETKAR, Dr

  CIDP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: March 19, 2025
• Primary Completion: November 15, 2025
• Study Completion: January 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)