DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS

Official Title
-----------------
DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

Conditions
-----------------
Dandruff

Intervention / Treatment
-----------------
* Other: Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with dandruff or seborrheic dermatitis All hair types All ethnicities (Asian, Caucasian, Afro-American, African, Hispanic) Including patients with specific occlusion habits (for instance veil use at least 8 hours per day, hat use) Patients willing to provide written informed consent Exclusion Criteria: Under 12 years old Pregnancy, breast feeding, childbearing potential without adequate contraception, or irregular menstrual cycles. History of allergy, anaphylaxis or hypersensitivity to any of the ingredients of Shampoo any of the ingredients of DERCOS ANTI-DANDRUFF normal to oily hair shampoo History of allergic contact dermatitis secondary to shampoo, conditioner, mask, and/or leave-in. Has any clinical manifestations in the treatment(s) or other disorders that, in the opinion of the investigator, may affect the evaluations or results of the study products.- Inability to stay the study period (56 days +-5 days) without performing any hair/scalp procedure, including coloring, straightening and cutting. Inability to attend all study visits and follow treatment regimen

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)|to assess the benefit of Dercos DS in subjects with dandruff|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desquamation | Scale (0=absence to 4= very severe) | Baseline | 
| Desquamation | Scale (0=absence to 4= very severe) | Day 28 | 
| Desquamation | Scale (0=absence to 4= very severe) | Day 56 | 
| Irritation | Scale (0=absence to 4= very severe) | baseline | 
| Irritation | Scale (0=absence to 4= very severe) | Day 28 | 
| Irritation | Scale (0=absence to 4= very severe) | Day 56 | 
| Erythema | Scale (0=absence to 4= very severe) | baseline | 
| Erythema | Scale (0=absence to 4= very severe) | Day 28 | 
| Erythema | Scale (0=absence to 4= very severe) | Day 56 | 
| Itching | Scale (0=absence to 10= very severe) | baseline | 
| Itching | Scale (0=absence to 10= very severe) | Day 28 | 
| Itching | Scale (0=absence to 10= very severe) | Day 56 | 
| Area involved | scale from <10% to >90% | baseline | 
| Area involved | scale from <10% to >90% | Day 28 | 
| Area involved | scale from <10% to >90% | Day 56 | 
| Tolerance | scale from 0= none to 5=very tolerated | baseline | 
| Tolerance | scale from 0= none to 5=very tolerated | Day 28 | 
| Improvement | scale from 0= worse to 5=very clearly improved | Day 28 | 
| Improvement | scale from 0= worse to 5=very clearly improved | Day 56 | 
| Impact of dandruff on patient | Scale from 0=not bothered at all to 5=very bothered | baseline | 
| Impact of dandruff on patient | Scale from 0=not bothered at all to 5=very bothered | Day 28 | 
| Impact of dandruff on patient | Scale from 0=not bothered at all to 5=very bothered | Day 56 | 
| Global evaluation by investigator | Scale from 0=not at all satisfactory at all to 4=very satisfactory | Day 28 | 
| Global evaluation by investigator | Scale from 0=not at all satisfactory at all to 4=very satisfactory | Day 56 | 
| Assessment of hair fiber and quality | scale from 0=worsened to 4=very improved | Day 56 | 
| Product respect/protects hair fiber | scale from 0=no, it is now more damaged/dry than before the treatment to 3=Yes, my hair fiber looks/feels better than before the treatment | Day 56 | 
| Patient product efficacy satisfaction | questionnare with scale ranging from 0=completely disagree to 5=completely agree | Day 28 | 
| Patient product efficacy satisfaction | questionnare with scale ranging from 0=completely disagree to 5=completely agree | Day 56 | 
| Patient product acceptability | scale ranging from 0=not satisfied at all to 10=very satisfied | Day 28 | 
| Patient product acceptability | scale ranging from 0=not satisfied at all to 10=very satisfied | Day 56 | 
| Patient global satisfaction | scale ranging from 0=not satisfied at all to 10=very satisfied | Day 28 | 
| Patient global satisfaction | scale ranging from 0=not satisfied at all to 10=very satisfied | Day 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dandruff, treatment satisfaction