Back to results

In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp

Primary Purpose

Pruritus of the Scalp

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

WO 5101 Shampoo for Scalp and Hair

About this trial

This is an interventional treatment trial for Pruritus of the Scalp focused on measuring itchy scalp, chronic pruritus

Eligibility Criteria

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

Inclusion Criteria:

age: ≥ 18 years
with chronically itchy scalp
normal to dry scalp or scalp prone to neurodermatitis

Exclusion Criteria:

any deviation from the above-mentioned criteria
users of sour hair conditioner
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 two weeks prior to starting of the study
systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within four weeks prior to starting of the study
severe internistic disease that leads to pruritus

Sites / Locations

SIT Skin Investigation and Technology Hamburg GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WO 5101 Shampoo for Scalp and Hair

Arm Description

WO 5101 is used in subjects with chronically itchy scalp

Outcomes

Primary Outcome Measures

Dermatological Tolerance of the Test Product on the Scalp

Change from Baseline at four weeks by the means of a dermatological assessment of scalp erythema edema dryness scaliness papules pustules fissures pruritus burning Tension all Parameters (a-j) were assessed by 6-tiered rating scale with 0.5 intervals (0=absent; 0.5=very slight, 1/1.5= slight; 2/2.5=moderate; 3/3.5=severe and 4=extreme)

Subjective Tolerance of the Test Product on the Scalp

Change from baseline at four weeks by means of a self-assessment questionnaire (with 13 questions regarding cosmetic features of the product as well as satisfaction with cosmetic performance).

Secondary Outcome Measures

Cosmetic Features of the Test Product

Change from Baseline for the Cosmetic Features (scalp feeling after application, fragrance, hair styling, combability, lightness of the hair) of the Test Product by the means of a questionnaire

Reduction of Pruritus

Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire

Full Information

NCT ID

NCT03630107

First Posted

August 6, 2018

Last Updated

August 13, 2018

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Collaborators

SIT Skin Investigation and Technology Hamburg GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03630107

Brief Title

In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp

Official Title

In-Use Test of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 15, 2018 (Actual)

Primary Completion Date

March 15, 2018 (Actual)

Study Completion Date

March 15, 2018 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use. Additional objective of this clinical in-use study was to evaluate the cosmetic features and the acceptance of the product by means of a questionnaire at the end of the 4-week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pruritus of the Scalp

Keywords

itchy scalp, chronic 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

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WO 5101 Shampoo for Scalp and Hair

Arm Type

Experimental

Arm Description

WO 5101 is used in subjects with chronically itchy scalp

Intervention Type

Other

Intervention Name(s)

WO 5101 Shampoo for Scalp and Hair

Intervention Description

Wash the hair at least three times a week for a period of four weeks

Primary Outcome Measure Information:

Title

Dermatological Tolerance of the Test Product on the Scalp

Description

Time Frame

baseline, four weeks

Title

Subjective Tolerance of the Test Product on the Scalp

Description

Change from baseline at four weeks by means of a self-assessment questionnaire (with 13 questions regarding cosmetic features of the product as well as satisfaction with cosmetic performance).

Time Frame

baseline, four weeks

Secondary Outcome Measure Information:

Title

Cosmetic Features of the Test Product

Description

Change from Baseline for the Cosmetic Features (scalp feeling after application, fragrance, hair styling, combability, lightness of the hair) of the Test Product by the means of a questionnaire

Time Frame

baseline, four weeks

Title

Reduction of Pruritus

Description

Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire

Time Frame

baseline, four weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age: ≥ 18 years with chronically itchy scalp normal to dry scalp or scalp prone to neurodermatitis Exclusion Criteria: any deviation from the above-mentioned criteria users of sour hair conditioner 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 two weeks prior to starting of the study systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within four weeks prior to starting of the study severe internistic disease that leads to pruritus

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerstin Söhl, 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

Learn more about this trial

In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp

We'll reach out to this number within 24 hrs