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| Results: |
Observations remained negative throughout the test interval. |
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| Summary: |
Under the conditions of this study, test material, Silver Glove Fabrics, did not indicate a potential for dermal irritation or allergic contact sensitization. |
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| Test Material: |
Miracle Wave Silver Glove Fabrics |
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| Objective: |
To determine by repetitive epidermal contact the potential of a test material to induce primary or cumulative irritation and/or allergic contact sensitization. |
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| Participants: |
Fifty-seven (57) qualified subjects, male and female, ranging in age from 17 to 77 years, were selected for this evaluation. Fifty-one (51) subjects completed this study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material. |
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| Inclusion Criteria: |
| a. |
Male and female subjects, age 16 and over. |
| b. |
Absence of any visible skin disease which might be confused with a skin reaction from the test material. |
| c. |
Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation. |
| d. |
Completion of a Medical History form and the understanding and signing of an Informed Consent form. |
| e. |
Considered reliable and capable of following directions. |
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| Methodology: |
The upper back between the scapulae served as the treatment area. Prior to the initiation of this study, test material was cut into approximately 1 x 1" pieces. This sample was then placed over the absorbent pad portion of an adhesive dressing and positioned to ensure that the dark silver side maintained direct skin contact and moistened with several drops of saline. When applied to the appropriate treatment site, this dressing formed an occlusive patch. |
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| Induction Phase: |
Patches were applied three (3) times per week (e.g., Monday, Wednesday, and Friday) for a total of nine (9) applications. The site was marked to ensure the continuity of patch application. Following supervised removal and scoring of the first Induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty-four hours after application. The evaluation of this site was made again just prior to re-application. If a participant was unable to report for an assigned test day, one (1) makeup day was permitted. This day was added to the Induction period.
With the exception of the first supervised Induction Patch reading, if any test site exhibited a moderate (2-level) reaction during the Induction Phase, application was moved to an adjacent area. Applications were discontinued for the remainder of this test phase, if a moderate (2-level) reaction was observed on this new test site. Applications would also be discontinued if marked (3-level) or severe (4-level) reactivity was noted.
Rest periods consisted of twenty-four hours following each Tuesday and Thursday removal, and forty-eight hours following each Saturday removal. |
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| Challenge Phase: |
Approximately two (2) weeks after the final Induction patch application, a Challenge patch was applied to a virgin test site adjacent to the original Induction patch site, following the same procedure described for Induction. The patch was removed and the site scored at the clinic twenty-four and seventy-two hours post-application. |
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The test was conducted by Consumer Product Testing Co.,
Fairfield, New Jersey on June/July, 2002. |
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