Clinical trial NCT01368146: Human Repeat Insult Patch Test of Wound Dressings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Sensitization
Lead sponsor: Covalon Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Irritation
timeFrame: Assessed at induction phase (evaluated before reapplication; 9 applications over 3 weeks, reapplied after every 48 or 72 hrs) and challenge phase (single 48-hr application of test article to naive sites and evaluation 30 mins, 24 and 48 hrs post-removal
Secondary outcomes:
measure: Adhesion
timeFrame: Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application
measure: Pain upon removal
timeFrame: Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Hill Top Research
state: Florida
Study officials:
affiliation: Hill Top Research
name: Micah Humphrey, B.S.
role: PRINCIPAL_INVESTIGATOR
References: