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

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: Pruritus of the Scalp
• Intervention / Treatment: Other: WO 5101 Shampoo for Scalp and Hair

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20354
    • SIT Skin Investigation and Technology Hamburg GmbH

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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	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)	baseline, four weeks
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).	baseline, four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, four weeks
Reduction of Pruritus	Change from Baseline Reduction of Pruritus at four weeks by the means of a questionnaire	baseline, four weeks

Collaborators and Investigators

• 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

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: chronic pruritus; itchy scalp
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• 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