Human Repeat Insult Patch Test of Wound Dressings

Covalon Technologies

Status and phase

Completed

Phase 1

Conditions

Skin Sensitization

Treatments

Device: Tegaderm CHG™

Device: Silicone Vehicle Control Dressing

Device: IV Clear™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01368146

TP-015

Details and patient eligibility

About

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.

Full description

A single center, within-subject randomized study design in healthy adult subjects. Qualified subjects will complete three phases of the study (induction, rest and challenge).

Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.

Enrollment

216 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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