Status:
ACTIVE_NOT_RECRUITING
Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks Treatment and 12 Weeks Remanence
Lead Sponsor:
Vichy Laboratoires
Collaborating Sponsors:
Eurofins
Conditions:
Dandruff
Eligibility:
All Genders
18+ years
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 we...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07133334
Start Date
April 2 2025
End Date
September 30 2025
Last Update
August 21 2025
Active Locations (1)
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1
Eurofins
Quatre Bornes, Mauritius