NCT03024671

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

February 10, 2017

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

8.8 years

First QC Date

January 11, 2017

Last Update Submit

November 14, 2024

Conditions

Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with positive patch test reactions to cosmetics

    Inflammation of Skin at test patch location

    4 weeks

Study Arms (1)

patch test

EXPERIMENTAL

Patients with patch test of cosmetics

Other: Patch test application

Interventions

Patch test applicationOTHER

test patch with cosmetic product will be applied to the back

patch test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital Bern

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dagmar Simon, MD

    Dept. of Dermatology, Inselspital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dagmar Simon, MD

CONTACT

+41 31 632 2278dagmar.simon@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 19, 2017

Study Start

February 10, 2017

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

single centered study

Locations

CH(1)