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

NCT07133334 | Completed

• 1 other identifier: VCY 24-011
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

Study Arms (2)

Routine Dercos

Shampoo + conditionner

Other: Selenium disulfide; Other: Piroctone olamine

Shampoo alone Dercos

Shampoo

Other: Selenium disulfide

Interventions

Selenium disulfide OTHER

1% SeS2

Routine Dercos; Shampoo alone Dercos

Piroctone olamine OTHER

0.5% piroctone olamine

Routine Dercos

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 in Quatre-Borne in Mauritius

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vichy Laboratoires: lead
• Eurofins: collaborator

Study Sites (1)

Eurofins

Quatre Bornes, Mauritius

Location

MeSH Terms

Conditions

Dandruff

Interventions

selenium disulfide; piroctone olamine

Condition Hierarchy (Ancestors)

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

Study Officials

• Ashlam DOARIKA, Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 21, 2025
• Study Start: April 2, 2025
• Primary Completion: August 18, 2025
• Study Completion: September 30, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)