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

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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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

Yes

Description

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

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 5101 Shampoo for Scalp and Hair
WO 5101 is used in subjects with chronically itchy scalp
Other: WO 5101 Shampoo for Scalp and Hair
Wash the hair at least three times a week for a period of four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatological Tolerance of the Test Product on the Scalp
Time Frame: baseline, four weeks

Change from Baseline at four weeks by the means of a dermatological assessment of scalp

  1. erythema
  2. edema
  3. dryness
  4. scaliness
  5. papules
  6. pustules
  7. fissures
  8. pruritus
  9. burning
  10. 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)
baseline, four weeks
Subjective Tolerance of the Test Product on the Scalp
Time Frame: baseline, four weeks
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).
baseline, four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic Features of the Test Product
Time Frame: baseline, four weeks
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
baseline, four weeks
Reduction of Pruritus
Time Frame: baseline, four weeks
Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire
baseline, four 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: Kerstin Söhl, 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)

February 15, 2018

Primary Completion (Actual)

March 15, 2018

Study Completion (Actual)

March 15, 2018

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Estimated)

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

  • LPS-05/2017

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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