In-Use Test With a Cosmetic Product

In-Use Test With a Cosmetic Product (WO 4260) for Topical Use on the Scalp

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Other: WO 4260 Cosmetic Product for Topical Use

• 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
• Genders Eligible for Study: All

Description

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

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 4260 Cosmetic Product for Topical Use; WO 4260 is used to treat dry and itchy scalp	Other: WO 4260 Cosmetic Product for Topical Use; Application on the hair scalp at least once a day over four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of the Test Product on the Scalp	Change from Baseline Tolerance on the Scalp at 4 weeks	after 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Hydration of the Scalp	The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology)	before product treatment; after 2 and 4 weeks of treatment
Performance of the Test Product	Subjective assessment of product performance in a questionnaire-based interview	after 4 weeks of treatment
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.	after 2 weeks of treatment

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: SIT Skin Investigation and Technology Hamburg GmbH
• Investigators: Study Director: Mona Mazinani, MD, SIT Skin Investigation and Technology Hamburg GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): February 27, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Dry scalp; Itchy scalp
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: LPT-15/2016

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