Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks of Treatment and 12 Weeks Remanence n Subjects With Moderate to Severe Dandruff
| Registry | NCT07133334 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 80 (Actual) |
| Sponsor | Vichy Laboratoires (Industry); collaborators: Eurofins |
| Conditions | Dandruff |
| Interventions | Selenium disulfide, Piroctone olamine (Other) |
| Dates | start 2025-04-02, primary completion 2025-08-18, completion 2025-09-30, first posted 2025-08-21, last updated 2026-03-04 |
| Locations | 1 site in Mauritius |
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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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Routine Dercos | Other: Selenium disulfide; Other: Piroctone olamine | Shampoo + conditionner | |
| Shampoo alone Dercos | Other: Selenium disulfide | Shampoo |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Eurofins | Quatre Bornes | Mauritius |