Dandruff
Conditions
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 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
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, 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.
Interventions
OTHERSelenium disulfide
1% SeS2
OTHERPiroctone olamine
0.5% piroctone olamine
Sponsors
Vichy Laboratoires
Eurofins
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 (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dandruff evaluation (non adherent and adherent) | Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16 | 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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16 | 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 | Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16 | 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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16 | 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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16 | — |
| Efficacy and cutaneaous acceptability | Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16 | Questionnaire with 5 proposition for each question: completely agree, somewhat agree, neitheir agree or disagree, somewhat disagree, completely disagree |
Countries
Mauritius
Contacts
PRINCIPAL_INVESTIGATORAshlam DOARIKA, Dr
Outcome results
None listed