In-Use Test With a Cosmetic Product to Treat Pruritus

Not Applicable

Completed

• Conditions: Pruritus
• Interventions: Other: WO 3308 cosmetic product for topical use

• Registration Number: NCT03477058
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-23
• Primary Completion: 2017-02-06
• Study Completion: 2017-02-06
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WO 3308 cosmetic product for topical use	WO 3308 cosmetic product for topical use	WO 3308 is used to treat acute or chronic pruritus

Primary Outcome Measures

Name	Time	Method
Cosmetic Features of the Test Product	baseline, two weeks	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
Reduction of Pruritus	baseline, two weeks	Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire

Secondary Outcome Measures

Name	Time	Method
Tolerance of the Test Product on the skin	baseline, two weeks	Change from baseline at two weeks by the means of a dermatological and subjective assessment of skin tolerance on arms and legs

Trial Locations

Locations (1)

SIT Skin Investigation and Technology Hamburg GmbH; 🇩🇪 Hamburg, Germany