In-Use Test With a Cosmetic Product

Not Applicable

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Other: WO 4260 Cosmetic Product for Topical Use

• Registration Number: NCT03252730
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-30
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Study First Submitted: 2017-07-18
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-17
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WO 4260 Cosmetic Product for Topical Use	WO 4260 Cosmetic Product for Topical Use	WO 4260 is used to treat dry and itchy scalp

Primary Outcome Measures

Name	Time	Method
Tolerance of the Test Product on the Scalp	after 4 weeks of treatment	Change from Baseline Tolerance on the Scalp at 4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SIT Skin Investigation and Technology Hamburg GmbH; 🇩🇪 Hamburg, Germany