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

NCT ID: NCT07133334

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-02
• Study Completion Date: 2025-09-30

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

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.

Conditions

Dandruff

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Routine Dercos

Shampoo + conditionner

Selenium disulfide

Intervention Type: OTHER

1% SeS2

Piroctone olamine

Intervention Type: OTHER

0.5% piroctone olamine

Shampoo alone Dercos

Shampoo

Selenium disulfide

Intervention Type: OTHER

1% SeS2

Interventions

Selenium disulfide

1% SeS2

Intervention Type: OTHER

Piroctone olamine

0.5% piroctone olamine

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins

INDUSTRY

Sponsor Role: collaborator

Vichy Laboratoires

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashlam DOARIKA, Dr

Role: PRINCIPAL_INVESTIGATOR

Locations

Eurofins

Quatre Bornes, , Mauritius

Countries

Mauritius

Other Identifiers

VCY 24-011

Identifier Type: -

Identifier Source: org_study_id