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
About this trial
This is an interventional treatment trial for Pruritus focused on measuring chronic pruritus, acute pruritus
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
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
NCT ID
NCT03477058
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
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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