- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088685
Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel
October 4, 2011 updated by: Johnson & Johnson Consumer and Personal Products Worldwide
Feasibility Study to Evaluate the Safety and Performance of a Hydrogel Blister Patch Prototype for the Treatment of Foot Blisters
Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hamburg, Germany, 20354
- SCIderm GmbH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Blister Patch
Experimental Hydrogel Blister patch
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Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals
Other Names:
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Active Comparator: Marketed Pflaster
Scholls Blasen Pflaster
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Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigator Assessment
Time Frame: at subject's last visit, within 14 days of start
|
Global assessment of the product by the investigator at the subject's last visit.
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at subject's last visit, within 14 days of start
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Assessment
Time Frame: at subject's last visit, within 14 days of start
|
Global assessment of the product by the subject at the subject's last visit.
|
at subject's last visit, within 14 days of start
|
Time to Heal
Time Frame: Baseline to subject's last visit, within 14 days of start
|
Record of the time it took for the blister to heal within the 14-day study period.
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Baseline to subject's last visit, within 14 days of start
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Qing Li, PhD, J&J Consumer and Personal Products Worldwide
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
March 16, 2010
First Submitted That Met QC Criteria
March 16, 2010
First Posted (Estimate)
March 17, 2010
Study Record Updates
Last Update Posted (Estimate)
October 6, 2011
Last Update Submitted That Met QC Criteria
October 4, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNKEDI0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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