Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel

NCT01088685 | Completed

• 1 other identifier: UNKEDI0001
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blister

Outcome Measures

Primary Outcomes (1)

• Investigator Assessment

  Global assessment of the product by the investigator at the subject's last visit.

  at subject's last visit, within 14 days of start

Secondary Outcomes (2)

• Subject Assessment

  at subject's last visit, within 14 days of start

• Time to Heal

  Baseline to subject's last visit, within 14 days of start

Study Arms (2)

Experimental Blister Patch

EXPERIMENTAL

Experimental Hydrogel Blister patch

Device: Experimental Blister Patch

Marketed Pflaster

ACTIVE COMPARATOR

Scholls Blasen Pflaster

Device: Marketed Pflaster

Interventions

Experimental Blister Patch DEVICE

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

Also known as: No trade name available - not a marketed product

Experimental Blister Patch

Marketed Pflaster DEVICE

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

Also known as: Scholls Blasen Pflaster

Marketed Pflaster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

SCIderm GmbH

Hamburg, 20354, Germany

Location

MeSH Terms

Conditions

Blister

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Qing Li, PhD

  J&J Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

DE (1)