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

N/AActive Not RecruitingNCT07133334

Vichy Laboratoires80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dandruff

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.