In-Use Test With a Cosmetic Product | NCT03252730

Studies
In-Use Test With a Cosmetic Product

NCT03252730

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Status

Completed

Last Update Posted

Aug 22, 2017Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Dermatitis, Atopic

Interventions

WO 4260 Cosmetic Product for Topical Use

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2017Actual

Primary Completion Date

Feb 27, 2017Actual

Completion Date

Feb 27, 2017Actual

First Submitted Date

Jul 18, 2017

First Submission Date that Met QC Criteria

Aug 16, 2017

First Posted Date

Aug 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2017

Last Update Posted Date

Aug 22, 2017Actual

Name	Class
SIT Skin Investigation and Technology Hamburg GmbH	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WO 4260 Cosmetic Product for Topical Use	Experimental	WO 4260 is used to treat dry and itchy scalp	Other: WO 4260 Cosmetic Product for Topical Use

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WO 4260 Cosmetic Product for Topical Use	Other	Application on the hair scalp at least once a day over four weeks	WO 4260 Cosmetic Product for Topical Use

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mona Mazinani, MD	SIT Skin Investigation and Technology Hamburg GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SIT Skin Investigation and Technology Hamburg GmbH		Hamburg		20354	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

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