Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel

NCT ID: NCT01088685

Last Updated: 2011-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-11-30

Brief Summary

Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.

Detailed Description

The study will require participation for up to 14 days of participation or less if the blister heals sooner, will recruit 100 subjects with fluid filled blisters on the heel of the foot that are intact and not broken. Some subjects will be asked to have their blisters photographed. All subjects will be required to have their blister unroofed (top layer of skin removed by the physician using sterile instruments). All subjects will receive study product, either test product or a marketed product.

Conditions

Blister

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Blister Patch

Experimental Hydrogel Blister patch

Group Type: EXPERIMENTAL

Experimental Blister Patch

Intervention Type: DEVICE

Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals

Marketed Pflaster

Scholls Blasen Pflaster

Group Type: ACTIVE_COMPARATOR

Marketed Pflaster

Intervention Type: DEVICE

Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals

Interventions

Experimental Blister Patch

Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals

Intervention Type: DEVICE

Marketed Pflaster

Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals

Intervention Type: DEVICE

Other Intervention Names

No trade name available - not a marketed product; Scholls Blasen Pflaster

Eligibility Criteria

Inclusion Criteria

• Male or female subjects, 18 years of age or older;
• Individuals who are willing and able to provide informed consent
• Female subjects of child bearing potential must have a negative urine pregnancy test prior to application of the study products;
• Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 such as the ones listed below and agree to continue using this method during their participation in the study; Note that abstinence is not an approved method of birth control.

• Postmenopausal or amenorrheic for one year
• Surgically sterile (hysterectomy, tubal ligation, or oophorectomy)
• Use of an effective method of birth control (e.g. prescription oral contraceptives, contraceptive implants or injections, intrauterine device, diaphragm, cervical cap or condoms with spermicide)
• Individuals exhibit a blister on the heel that is determined by the investigator to be no more than 72 hours old and in stage 2
• Subject is willing to have blister unroofed (top layer of blister removed) by the investigator
• Subject is willing and able to follow the study directions, to participate in the study, and to return for all specified visits

Exclusion Criteria

• Pregnant, planning a pregnancy or actively nursing
• Exhibits a foot blister on the heel that exceeds 1125mm2 or would otherwise not be covered by the hydrogel portion of the study product
• Unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study
• Individuals with autoimmune disorders including, but not limited to, lupus erythematosus, rheumatoid arthritis, or HIV/AIDS
• Currently participating in or, within the past 30 days have participated in another clinical study using an investigational drug or device
• Employees of the site, or friends/relatives of employees that would have access to study information
• Diabetic, type I or type II
• Treatment for any type of cancer within the last 2 years or history of skin cancer
• Damaged skin in or around test sites, which include sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, acne, and disfiguration of the test site
• History of clinically determined allergic reaction or irritation to any of the test product ingredients
• History of or known allergy to iodine
• Currently taking or expected to take any of the following during the course of the study: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Li, PhD

Role: STUDY_DIRECTOR

J&J Consumer and Personal Products Worldwide

Locations

SCIderm GmbH

Hamburg, , Germany

Countries

Germany

Other Identifiers

UNKEDI0001

Identifier Type: -

Identifier Source: org_study_id