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Study Reference No. - 19-021

Demographic Gender Age Location Compensation
Healthy,having Fitzpatrick I-VI skin types Any 18-70 Winnipeg, MB $450
Study Details

Study Purpose

The study to determine whether the tattoo product (either open or semi-occluded) produces cumulative irritation reactions or any dermal reactions that might be indicative of allergic contact dermatitis.
Study participants will test skin irritation and sensitization through tattoo and patch application on their inner forearms, shoulders and upper back during a 15-visits research study.

Study Duration

1 Screening Visit (45 minutes)
14 Additional Visits over 5-6 Weeks
Total 15 Visits

Study Schedule

General Screening

9/16/2019 and 9/17/2019

Medical Screening

N/A

Study Visit(s)

Visit 1 (45 minutes)
Informed Consent, medical history, inclusion/exclusion questions.
Visit 2 (2.5 hours)
Medical history, for females of child bearing potential - urine pregnancy test, sit for 10 min in ambient environmental condition prior to skin safety check, TA and patch application, photographs.
Visit 3 (1.5 hours)
Patch application and removal, AE review, Visual Evaluation and photographs
Visit 4 (1.5 hours)
Patch application and removal, AE review, Visual Evaluation and photographs
Visit 5 (2 hours)
TA application, Patch application and removal, AE review, Visual Evaluation and photographs
Visit 6 (1.5 hours)
Patch application and removal, AE review, Visual Evaluation and photographs
Visit 7 (1.5 hours)
Patch application and removal, AE review, Visual Evaluation and photographs
Visit 8 (2 hours)
TA application, Patch application and removal, AE review, Visual Evaluation and photographs
Visit 9 (1.5 hours)
Patch application and removal, AE review, Visual Evaluation and photographs
Visit 10 (1.5 hours)
Patch application and removal, AE review, Visual Evaluation and photographs
Visit 11 (1.5 hours)
Patch removal, AE review, Visual Evaluation and photographs
Visit 12 (2.5 hours)
Urine pregnancy test (if applicable), sit for 10 min in ambient environmental condition prior to skin safety check, TA and patch application, photographs.
Visit 13 (1.5 hours)
Patch removal, AE review, Visual Evaluation, photographs, Patch application
Visit 14 (1.5 hour)
Patch removal, AE review, Visual Evaluation, photographs, Patch application
Visit 15 (1.0 hour)
Patch removal, AE review, Visual Evaluation and photographs
Total 15 Visits

Follow-Up Visit(s)

Investigator will decide if require.

Other Notes

Bring valid ID
$50 referral incentive
May be excluded if skin type is not as per study requirement.