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In-Use Test With a Cosmetic Product

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
WO 4260 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 Dermatitis, Atopic focused on measuring Dry scalp, Itchy scalp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age: ≥ 18 years
  • sex: approx. 50% male and approx. 50% female
  • users of hair tonic for dry scalp
  • dry, itchy scalp prone to atopic eczema / atopic dermatitis

Exclusion Criteria:

  • any deviation from the above-mentioned criteria
  • users of sour hair rinse
  • subjects who wash their hair more than once a day
  • other dermatological disorders (scars, moles) on the scalp
  • 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 anti-inflammatory agents and antibiotics within 2 weeks prior to starting of the study
  • systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting of the study
  • systemic illness of the subject at the beginning of the study
  • 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 4260 Cosmetic Product for Topical Use

Arm Description

WO 4260 is used to treat dry and itchy scalp

Outcomes

Primary Outcome Measures

Tolerance of the Test Product on the Scalp
Change from Baseline Tolerance on the Scalp at 4 weeks

Secondary Outcome Measures

Skin Hydration of the Scalp
The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology)
Performance of the Test Product
Subjective assessment of product performance in a questionnaire-based interview
Tolerance of the Test Product on the Scalp
Dermatological assessment of the Scalp concerning the Tolerance of the Test Product regarding erythema, edema dryness etc. Each item is scored 0=absent to 4=extreme.

Full Information

First Posted
July 18, 2017
Last Updated
August 17, 2017
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
NCT03252730
Brief Title
In-Use Test With a Cosmetic Product
Official Title
In-Use Test With a Cosmetic Product (WO 4260) for Topical Use on the Scalp
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
February 27, 2017 (Actual)
Study Completion Date
February 27, 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 tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Dry scalp, Itchy scalp

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
WO 4260 Cosmetic Product for Topical Use
Arm Type
Experimental
Arm Description
WO 4260 is used to treat dry and itchy scalp
Intervention Type
Other
Intervention Name(s)
WO 4260 Cosmetic Product for Topical Use
Intervention Description
Application on the hair scalp at least once a day over four weeks
Primary Outcome Measure Information:
Title
Tolerance of the Test Product on the Scalp
Description
Change from Baseline Tolerance on the Scalp at 4 weeks
Time Frame
after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Skin Hydration of the Scalp
Description
The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology)
Time Frame
before product treatment; after 2 and 4 weeks of treatment
Title
Performance of the Test Product
Description
Subjective assessment of product performance in a questionnaire-based interview
Time Frame
after 4 weeks of treatment
Title
Tolerance of the Test Product on the Scalp
Description
Dermatological assessment of the Scalp concerning the Tolerance of the Test Product regarding erythema, edema dryness etc. Each item is scored 0=absent to 4=extreme.
Time Frame
after 2 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age: ≥ 18 years sex: approx. 50% male and approx. 50% female users of hair tonic for dry scalp dry, itchy scalp prone to atopic eczema / atopic dermatitis Exclusion Criteria: any deviation from the above-mentioned criteria users of sour hair rinse subjects who wash their hair more than once a day other dermatological disorders (scars, moles) on the scalp 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 anti-inflammatory agents and antibiotics within 2 weeks prior to starting of the study systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting of the study systemic illness of the subject at the beginning of the study pregnancy and period of breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Mazinani, MD
Organizational Affiliation
SIT Skin Investigation and Technology Hamburg GmbH
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

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In-Use Test With a Cosmetic Product

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