In-Use Test With a Cosmetic Product

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.

Official Title
-----------------
In-Use Test With a Cosmetic Product (WO 4260) for Topical Use on the Scalp

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Other: WO 4260 Cosmetic Product for Topical Use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: ≥ 18 years sex: approx. 50% male and approx. 50% female users of hair tonic for dry scalp dry, itchy scalp prone to atopic eczema / atopic dermatitis Exclusion Criteria: any deviation from the above-mentioned criteria users of sour hair rinse subjects who wash their hair more than once a day other dermatological disorders (scars, moles) on the scalp known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI) topical medication in the test area within 1 month prior to study start systemic medication with anti-inflammatory agents and antibiotics within 2 weeks prior to starting of the study systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting of the study systemic illness of the subject at the beginning of the study pregnancy and period of breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WO 4260 Cosmetic Product for Topical Use<br>WO 4260 is used to treat dry and itchy scalp | Other: WO 4260 Cosmetic Product for Topical Use<br>* Application on the hair scalp at least once a day over four weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of the Test Product on the Scalp | Change from Baseline Tolerance on the Scalp at 4 weeks | after 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Hydration of the Scalp | The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology) | before product treatment; after 2 and 4 weeks of treatment | 
| Performance of the Test Product | Subjective assessment of product performance in a questionnaire-based interview | after 4 weeks of treatment | 
| Tolerance of the Test Product on the Scalp | Dermatological assessment of the Scalp concerning the Tolerance of the Test Product regarding erythema, edema dryness etc. Each item is scored 0=absent to 4=extreme. | after 2 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry scalp, Itchy scalp