In-Use Test With a Cosmetic Product

Not Applicable

Completed

• Conditions: Dermatitis, Atopic

• 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

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