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Epicutaneous Testing of Cosmetics

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT03024671
Collaborator
Mibelle AG (Industry)
180
Enrollment
1
Location
1
Arm
105.7
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patch test application
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Epicutaneous Testing of Cosmetic Products to Determine Skin Compatibility
Actual Study Start Date :
Feb 10, 2017
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: patch test

Patients with patch test of cosmetics

Other: Patch test application
test patch with cosmetic product will be applied to the back

Outcome Measures

Primary Outcome Measures

  1. Number of patients with positive patch test reactions to cosmetics [4 weeks]

    Inflammation of Skin at test patch location

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inselspital Bern Bern Switzerland

Sponsors and Collaborators

  • University Hospital Inselspital, Berne
  • Mibelle AG

Investigators

  • Principal Investigator: Dagmar Simon, MD, Dept. of Dermatology, Inselspital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT03024671
Other Study ID Numbers:
  • KEK-BE 2016-01686
First Posted:
Jan 19, 2017
Last Update Posted:
Sep 13, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dermatitis

Study Results

No Results Posted as of Sep 13, 2019