Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks With 1 Application Per Week (Maintenance Phase) on Subjects With Moderate to Severe Dandruff and Severe Itching State.
Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks With 1 Application Per Week (Maintenance Phase) on Subjects With Moderate to Severe Dandruff and Severe Itching State.
The goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state.
Participants will:
Apply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products
=> after 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase)
Primary objective :
• To evaluate the reduction of total dandruff ( adherent and non-adherent)
Secondary objectives:
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 (The groups must be balanced to ensure an equitable distribution)
All types of scalp.
Any phototype
Questionnaire inclusion: Food habits and sleep (at least 30 vols per item, a subject can be included in both groups)
Severe itching score ≥ 7
Subject with hair length > 2 cm.
Subject 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.
Subject usually using a shampoo 3 times a week and accepting to follow a rate of 3 times a week during the whole study period.
Subject agreeing not to use any other hair product other than the ones provided for the study (till the end of study); in particular:
Subject agreeing not to have a short haircut during the entire study period.
Subjects in good general and mental health in the opinion of the investigator
Subjects demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form
Subjects who have agreed to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
Exclusion Criteria:
Subject with scalp psoriasis
Subject with more than 60% of white hair influencing the scoring of scales.
Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
Subject with alopecia in vertex (stage > IIIa Hamilton and > I Ludwig)
Subject who has used topic treatment for the scalp (anti-hair loss, soothing…) during the last three weeks before the start of the study.
Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study.
Subject with history of allergy and/or reactions to latex.
Subject who has taken:
Subject practicing regularly water sport and/or having regular sauna sessions.
Subject exposed to the sun or UV rays in an excessive way during the last month (according to the investigator).
Pregnancy, breastfeeding, 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 the start of the study.
Systemic use of erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study
Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)
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 pectoris)
Treatment with any other investigational drug in the 4 weeks prior to study entry
Employee of the sponsor or the study site