- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170586
Novel Protective Underglove
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78216
- Biomedical Development Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Aim 2a. and Aim 2b1. and Aim 2b2.
- greater than 18 years of age;
- healthy subjects as determined by brief medical history;
- skin in the test area must be devoid of tattoos, scars, moles, vitiligo, keloids, or breaks in the skin;
- capable of reading, understanding and signing the consent form.
Aim 3.
- Males/females, 18-70 years of age;
- healthy subjects as determined by medical history;
- capable of reading, understanding and signing the consent form.
Aim 2.
- 18-72 years of age;
- healthy subjects as determined by a brief medical history;
- capable of reading, understanding and signing the consent form;
- skin in the test area must be devoid of tattoos, scars, moles, vitiligo, keloids, or breaks in the skin.
Exclusion Criteria:
Aim 2a. and Aim 2b1. and Aim 2b2. and Aim 2.
- history or current evidence of a chronic or infectious skin disease
- pregnant or lactating females. Participating female subjects must agree to use adequate contraceptive measures during the trial. Before entering the study, women of childbearing age will be tested for pregnancy.
Aim 3.
1) active, clinically significant skin diseases such as eczema, atopic dermatitis, psoriasis and skin cancer; 2) severe, chronic asthma; 3) insulin dependent diabetes mellitus or hyperthyroidism (metabolic diseases); 4) routine use of anti-inflammatory medications (i.e., aspirin, ibuprofen, corticosteroids, immunosuppressive drugs or anti-histamines; 5) use of topical drugs at test sites; 6) immunological disorders such as HIV positive, AIDS or systemic lupus erythematosus; 7) participation in any patch test for cumulative irritation or sensitization within the last four weeks; 8) women who are pregnant, lactating, or planning to become pregnant within the next six weeks; 9) mastectomy for cancer involving removal of the lymph nodes; 10) allergy to tapes; 11) subject who has damaged skin in or around test sites which include sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site; 12) subject who has a condition or is taking or had taken a medication which, in the Investigator's judgement, makes the subject ineligible or places the subject at undue risk; 13) subject who has sensitivity to any of the ingredients in the test articles.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-241
- PHS 2002-2
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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