Dandruff
Conditions
Brief summary
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
Detailed description
=\> 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: * To evaluate the Quality of Life (QoL) evolution * To evaluate the reduction of discomfort (itching, stinging, burning sensation) * To evaluate the reduction of scales * To assess the cosmetic properties of investigational product * To assess the tolerance of investigational product
Interventions
OTHERSelenium disulfide
1% SeS2
Sponsors
Vichy Laboratoires
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * 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 coloring or hair bleaching within one week prior to any study visit. * 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: * Corticoids (local or per os) within 2 weeks before the study entry * Anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive orlithium-based drugs less than 1 month before the study entry, * retinoid acid (local or per os) since less than 6 months before study entry. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dandruff evaluation (non adherent and adherent) | Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-evaluation by subject of discomfort sensation (stinging, itching, burning sensation) on structured scale; | Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28 | Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result) |
| Self-evaluation by subject of dandruff state and greasy aspect on structured scale | Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result) | Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result) |
| Quality of life questionnaire - Scalpdex | Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28 | Publish questionnaire of quality of life, each item is evaluate with a 5-point scale from 0 (never, positive result) to 100 (always, negative result) |
| Standardized pictures of the scalp | Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28 | — |
| Efficacy and cutaneaous acceptability | Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28 | Questionnaire with 5 proposition for each question: completely agree, somewhat agree, neitheir agree or disagree, somewhat disagree, completely disagree |
Countries
Mauritius
Contacts
PRINCIPAL_INVESTIGATORGitanjali PETKAR, Dr
CIDP
Outcome results
None listed