In-Use Test With a Cosmetic Product to Treat Pruritus

December 18, 2023 updated by: Dr. August Wolff GmbH & Co. KG Arzneimittel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20354
        • SIT Skin Investigation and Technology Hamburg GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WO 3308 cosmetic product for topical use
WO 3308 is used to treat acute or chronic pruritus
Other: WO 3308 cosmetic product for topical use
Application on the entire body at least once a day over two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic Features of the Test Product
Time Frame: 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
baseline, two weeks
Reduction of Pruritus
Time Frame: baseline, two weeks
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
Time Frame: 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
baseline, two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Collaborators

SIT Skin Investigation and Technology Hamburg GmbH

Investigators

  • Study Director: Alexandra Gust, MD, Dermatologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2017

Primary Completion (Actual)

February 6, 2017

Study Completion (Actual)

February 6, 2017

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPC-17/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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