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

NCT ID: NCT03630107

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2018-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Pruritus of the Scalp

Keywords

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itchy scalp chronic pruritus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WO 5101 Shampoo for Scalp and Hair

WO 5101 is used in subjects with chronically itchy scalp

Group Type EXPERIMENTAL

WO 5101 Shampoo for Scalp and Hair

Intervention Type OTHER

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

Interventions

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WO 5101 Shampoo for Scalp and Hair

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SIT Skin Investigation and Technology Hamburg GmbH

OTHER

Sponsor Role collaborator

Dr. August Wolff GmbH & Co. KG Arzneimittel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kerstin Söhl, MD

Role: STUDY_DIRECTOR

Dermatologist

Locations

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SIT Skin Investigation and Technology Hamburg GmbH

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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LPS-05/2017

Identifier Type: -

Identifier Source: org_study_id