Human Repeat Insult Patch Test of Wound Dressings

Completed · Phase 1

Conditions studied: Skin Sensitization

In brief

The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.

Key facts

Study ID

NCT01368146

Run by

Covalon Technologies Inc.

People needed

216

Starts

2011-03-01

Expected to finish

2011-04-01

Last updated by the study team

2025-02-11

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, 18 years or older
• In good health, as determined by medical history and concomitant medication
• Able to comprehend and sign informed consent
• Unable to bear children or willing to use adequate birth control
• Willing and able to follow study directions, to participate in the study and to return for all specific visit

You may not qualify if…

• Subject pregnant, planning a pregnancy or lactating
• Diabetes (any type)
• Mastectomy involving removal of lymph nodes
• Clinically significant skin disease, including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
• Asthma or other severe respiratory disease requiring medication
• Self-reported immunological disorders including (but not limited to) HIV positive, AIDS, rheumatoid arthritis, and systematic lupus erythematosus
• Treatment of any type of cancer within the last two years or history of skin cancer in the test area
• Use of any of the following: topically applied products (e.g. medicals, lotions, creams, etc.) at the application site within 3 days of first application of test articles, immunosuppressive drugs within 30 days of first application of test articles, systemic or topical corticosteroids within 30 days of first application of test articles, and systemic or topically applied anti-inflammatory and antihistamine medications within 3 days of first application of test articles
• Participation in any patch test for irritation or sensitization within the last four weeks
• Participation in any investigational drug study within the last four weeks
• Damaged skin in or around the test sites which includes: sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfiguration
• Known sensitization to adhesives, bandages, or materials used in test articles
• Medical condition which, in investigator's judgment, makes the subject ineligible or places the subject at undue risk

Where it is running

• Hill Top Research — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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