In-Use Test With a Cosmetic Product to Treat Pruritus

Study Overview
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Brief Summary
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The aim of the study is to evaluate the cosmetic features of the product WO 3308 by means of a questionnaire in an interview situation after two weeks of product treatment, giving special consideration to the cosmetic performance, efficacy and skin compatibility and with special focus on the reduction of pruritus. Additionally the tolerance will be evaluated by a dermatologist.

Official Title
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In-Use Test With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic Pruritus

Conditions
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Pruritus

Intervention / Treatment
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* Other: WO 3308 cosmetic product for topical use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: ≥ 18 years sex: approx. 25% to 50% male and 50% to 75% female with acute pruritus (lasts less than 6 weeks) or chronic pruritus (lasts longer than 6 weeks): max. 50% with acute pruritus and at least 50% with chronic pruritus Exclusion Criteria: any deviation from the above-mentioned criteria 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 antibiotics within 2 weeks prior to starting of the study change in the medication with anti-inflammatory agents within 2 weeks prior to starting the study systemic medication with immunomodulators (immunsuppressive drugs in the course of a transplantation) and/or chemotherapeutic agents within 4 weeks prior to starting the study neurodermatitis (atopic dermatitis) pregnancy and period of breastfeeding

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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No

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 3308 cosmetic product for topical use<br>WO 3308 is used to treat acute or chronic pruritus | Other: WO 3308 cosmetic product for topical use<br>* Application on the entire body at least once a day over two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Features of the Test Product | Change from baseline for the cosmetic features (spreadability, absorbtion, skin feeling after application, fragrance) of the test product by the means of an interview-based questionnaire | baseline, two weeks | 
| Reduction of Pruritus | Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire | baseline, two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of the Test Product on the skin | Change from baseline at two weeks by the means of a dermatological and subjective assessment of skin tolerance on arms and legs | baseline, two weeks | 

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