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Epicutaneous Testing of Cosmetics for Skin Compatibility

Primary Purpose

Dermatitis

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Patch test application
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inselspital BernRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patch test

Arm Description

Patients with patch test of cosmetics

Outcomes

Primary Outcome Measures

Number of patients with positive patch test reactions to cosmetics
Inflammation of Skin at test patch location

Secondary Outcome Measures

Full Information

First Posted
January 11, 2017
Last Updated
February 20, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Mibelle AG
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1. Study Identification

Unique Protocol Identification Number
NCT03024671
Brief Title
Epicutaneous Testing of Cosmetics for Skin Compatibility
Official Title
Epicutaneous Testing of Cosmetic Products to Determine Skin Compatibility
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Mibelle AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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, as with allergic reactions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patch test
Arm Type
Experimental
Arm Description
Patients with patch test of cosmetics
Intervention Type
Other
Intervention Name(s)
Patch test application
Intervention Description
test patch with cosmetic product will be applied to the back
Primary Outcome Measure Information:
Title
Number of patients with positive patch test reactions to cosmetics
Description
Inflammation of Skin at test patch location
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dagmar Simon, MD
Phone
+41 31 632 2278
Email
dagmar.simon@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dagmar Simon, MD
Organizational Affiliation
Dept. of Dermatology, Inselspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dagmar Simon, MD
Phone
+41 31 632 2278
Email
dagmar.simon@insel.ch
First Name & Middle Initial & Last Name & Degree
Mark Wienand
Email
studynurse.derma@insel.ch

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
single centered study

Learn more about this trial

Epicutaneous Testing of Cosmetics for Skin Compatibility

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