In-Use Test With a Cosmetic Product

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252730
• Other study ID #: LPT-15/2016
• Status: Completed
• Phase: N/A
• First received: July 18, 2017
• Last updated: August 17, 2017
• Start date: January 30, 2017
• Est. completion date: February 27, 2017

Study information

• Verified date: August 2017
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Other:
• WO 4260 Cosmetic Product for Topical Use
Application on the hair scalp at least once a day over four weeks

Locations

Country	Name	City	State
Germany	SIT Skin Investigation and Technology Hamburg GmbH	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	Skin Investigation and Technology Hamburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of the Test Product on the Scalp	Change from Baseline Tolerance on the Scalp at 4 weeks	after 4 weeks of treatment
Secondary	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
Secondary	Performance of the Test Product	Subjective assessment of product performance in a questionnaire-based interview	after 4 weeks of treatment
Secondary	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