Epicutaneous Testing of Cosmetics for Skin Compatibility | NCT03024671

Studies
Epicutaneous Testing of Cosmetics for Skin Compatibility

NCT03024671

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Recruiting

Last Update Posted

Nov 19, 2024Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Dermatitis

Interventions

Patch test application

Countries

Switzerland

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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2017Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Jan 16, 2017

First Posted Date

Jan 19, 2017Estimated

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

Nov 14, 2024

Last Update Posted Date

Nov 19, 2024Actual

Name	Class
Mibelle AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 dermatological testing of cosmetic products which are new on the market, or existing products with novel formulations is common and a useful procedure, yet necessary to alleviate common irritants and contact allergic reactions. Cosmetic products contain a range of substances that may be considered as potential irritants or contact allergens. In order to estimate that risk, cosmetics are tested by applying patch tests.

Detailed Description

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

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patch test	Experimental	Patients with patch test of cosmetics	Other: Patch test application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patch test application	Other	test patch with cosmetic product will be applied to the back	patch test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with positive patch test reactions to cosmetics	Inflammation of Skin at test patch location	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women older than 18 years old
Persons undergoing a diagnostic patch test for reason of a skin disease
Signed written informed consent

Exclusion Criteria:

Acute skin inflammation and eczema on the back
Systemic corticosteroid and immunosuppressive therapy as well as UV exposure of the back within the last 4 weeks
Topical corticosteroids used on the back within the last two weeks

Accepts Healthy Volunteers

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

Name	Role	Phone	Extension	Email
Dagmar Simon, MD	Contact	+41 31 632 2278		dagmar.simon@insel.ch

Overall Officials

Name	Affiliation	Role
Dagmar Simon, MD	Dept. of Dermatology, Inselspital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inselspital Bern	Recruiting	Bern			Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

single centered study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003872	Dermatitis

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided