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In-Use Test With a Cosmetic Product to Treat Pruritus

Primary Purpose

Pruritus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
WO 3308 cosmetic product for topical use
Sponsored by
Dr. August Wolff GmbH & Co. KG Arzneimittel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring chronic pruritus, acute pruritus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SIT Skin Investigation and Technology Hamburg GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WO 3308 cosmetic product for topical use

Arm Description

WO 3308 is used to treat acute or chronic pruritus

Outcomes

Primary Outcome Measures

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
Reduction of Pruritus
Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2018
Last Updated
August 9, 2018
Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
SIT Skin Investigation and Technology Hamburg GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03477058
Brief Title
In-Use Test With a Cosmetic Product to Treat Pruritus
Official Title
In-Use Test With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
February 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
SIT Skin Investigation and Technology Hamburg GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
chronic pruritus, acute pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WO 3308 cosmetic product for topical use
Arm Type
Experimental
Arm Description
WO 3308 is used to treat acute or chronic pruritus
Intervention Type
Other
Intervention Name(s)
WO 3308 cosmetic product for topical use
Intervention Description
Application on the entire body at least once a day over two weeks
Primary Outcome Measure Information:
Title
Cosmetic Features of the Test Product
Description
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
Time Frame
baseline, two weeks
Title
Reduction of Pruritus
Description
Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire
Time Frame
baseline, two weeks
Secondary Outcome Measure Information:
Title
Tolerance of the Test Product on the skin
Description
Change from baseline at two weeks by the means of a dermatological and subjective assessment of skin tolerance on arms and legs
Time Frame
baseline, two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Gust, MD
Organizational Affiliation
Dermatologist
Official's Role
Study Director
Facility Information:
Facility Name
SIT Skin Investigation and Technology Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20354
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

In-Use Test With a Cosmetic Product to Treat Pruritus

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