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In-Use Test With a Cosmetic Product to Treat Pruritus

NCT ID: NCT03477058

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2017-02-06

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.

Detailed Description

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Conditions

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Pruritus

Keywords

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chronic pruritus acute pruritus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WO 3308 cosmetic product for topical use

WO 3308 is used to treat acute or chronic pruritus

Group Type EXPERIMENTAL

WO 3308 cosmetic product for topical use

Intervention Type OTHER

Application on the entire body at least once a day over two weeks

Interventions

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WO 3308 cosmetic product for topical use

Application on the entire body at least once a day over two weeks

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SIT Skin Investigation and Technology Hamburg GmbH

OTHER

Sponsor Role collaborator

Dr. August Wolff GmbH & Co. KG Arzneimittel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandra Gust, MD

Role: STUDY_DIRECTOR

Dermatologist

Locations

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SIT Skin Investigation and Technology Hamburg GmbH

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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LPC-17/2016

Identifier Type: -

Identifier Source: org_study_id