Human Repeat Insult Patch Test of Wound Dressings

NCT01368146 | Completed Phase 1

• 1 other identifier: TP-015
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Sensitization

Outcome Measures

Primary Outcomes (1)

• Irritation

  Irritation assessed at the induction phase will be scored on a Berger and Bowman Scale. Irritation assessed at the challenge phase will be scored on a defined scale measuring erythema reactions, ranging from no reaction to strong erythema.

  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 (2)

• Adhesion

  Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application

• Pain upon removal

  Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application

Study Arms (3)

IV Clear™

EXPERIMENTAL

Device: IV Clear™

Tegaderm CHG™

ACTIVE COMPARATOR

Device: Tegaderm CHG™

Control Vehicle Dressing

PLACEBO COMPARATOR

Device: Silicone Vehicle Control Dressing

Interventions

IV Clear™ DEVICE

Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver

IV Clear™

Tegaderm CHG™ DEVICE

Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate

Tegaderm CHG™

Silicone Vehicle Control Dressing DEVICE

Polyurethane film with silicone adhesive dressing, without antimicrobials

Control Vehicle Dressing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Covalon Technologies Inc.: lead

Study Sites (1)

Hill Top Research

St. Petersburg, Florida, 33710, United States

Location

Study Officials

• Micah Humphrey, B.S.

  Hill Top Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

US (1)