In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp

Study Overview
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Brief Summary
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The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use. Additional objective of this clinical in-use study was to evaluate the cosmetic features and the acceptance of the product by means of a questionnaire at the end of the 4-week treatment period.

Official Title
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In-Use Test of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp

Conditions
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Pruritus of the Scalp

Intervention / Treatment
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* Other: WO 5101 Shampoo for Scalp and Hair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: ≥ 18 years with chronically itchy scalp normal to dry scalp or scalp prone to neurodermatitis Exclusion Criteria: any deviation from the above-mentioned criteria users of sour hair conditioner 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 two weeks prior to starting of the study systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within four weeks prior to starting of the study severe internistic disease that leads to pruritus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WO 5101 Shampoo for Scalp and Hair<br>WO 5101 is used in subjects with chronically itchy scalp | Other: WO 5101 Shampoo for Scalp and Hair<br>* Wash the hair at least three times a week for a period of four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatological Tolerance of the Test Product on the Scalp | Change from Baseline at four weeks by the means of a dermatological assessment of scalp erythema edema dryness scaliness papules pustules fissures pruritus burning Tension all Parameters (a-j) were assessed by 6-tiered rating scale with 0.5 intervals (0=absent; 0.5=very slight, 1/1.5= slight; 2/2.5=moderate; 3/3.5=severe and 4=extreme) | baseline, four weeks | 
| Subjective Tolerance of the Test Product on the Scalp | Change from baseline at four weeks by means of a self-assessment questionnaire (with 13 questions regarding cosmetic features of the product as well as satisfaction with cosmetic performance). | baseline, four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Features of the Test Product | Change from Baseline for the Cosmetic Features (scalp feeling after application, fragrance, hair styling, combability, lightness of the hair) of the Test Product by the means of a questionnaire | baseline, four weeks | 
| Reduction of Pruritus | Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire | baseline, four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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itchy scalp, chronic pruritus