| Primary | Skin Irritation as Measured by Draize Score for Erythema and Edema | The Draize score (for each erythema and edema) has a range of 0 to 4, where a higher score indicated greater irritation. Individual scores below 3 were classified as not severe. | Each participant received all three types of adhesive. Data not collected on 9 participants. | Posted | | Mean | Standard Deviation | score on a scale | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
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| OG000 | Tanzanian Beeswax-pine Adhesive | Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. | | OG001 | Domestic Beeswax-pine Adhesive | Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. | | OG002 | Control | Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
| | | Title | Denominators | Categories |
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| Edema | | | Title | Measurements |
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| - OG0000.86± 0.28
- OG0010.03± 0.17
- OG0020± 0
|
| | Erythema | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation). | t-test, 1 sided | | <0.0001 | | Mean of paired differences | -0.2571 | Standard Deviation | 0.70 | 2-Sided | | | | | | | | Equivalence | Equivalence is defined as an average difference of < or = 2 | | |
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| Primary | Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale | The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the itching. The score ranges from 5 to 25, where a higher score indicates greater itching. | | Posted | | | | | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
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| OG000 | Tanzanian Beeswax-pine Adhesive | Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. | | OG001 | Domestic Beeswax-pine Adhesive | Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. | | OG002 | Control | Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Primary | Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?" | | Each participant received all three types of adhesive. Data not collected on 2 participants. | Posted | | Count of Participants | | Participants | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
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| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Primary | Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks" | | Each participant received all three types of adhesive. Data not collected on 2 participants. | Posted | | Count of Participants | | Participants | | Assessed daily up to 14 days, day 14 reported | | | | ID | Title | Description |
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| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Primary | Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" | | Each participant received all three types of adhesive. Data not collected on 2 participants. | Posted | | Count of Participants | | Participants | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Primary | Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week" | | Each participant received all three types of adhesive. Data not collected on 2 participants. | Posted | | Count of Participants | | Participants | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
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| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Primary | Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week" | | Each participant received all three types of adhesive. Data not collected on 2 participants. | Posted | | Count of Participants | | Participants | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Primary | Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week" | | Each participant received all three types of adhesive. Data not collected on 2 participants. | Posted | | Count of Participants | | Participants | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Primary | Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week" | | Each participant received all three types of adhesive. Data not collected on 2 participants. | Posted | | Count of Participants | | Participants | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Primary | Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body" | | Each participant received all three types of adhesive. Data not collected on 2 participants. | Posted | | Count of Participants | | Participants | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Secondary | Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection | | Each participant received all three types of adhesive. Data were collected on the whole participant level for the reported adverse events data. | Posted | | Count of Participants | | Participants | | Assessed daily up to 7 days, day 7 reported | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Secondary | Overall Well-being as Measured by Daily Survey | Number of participants who responded "yes" to the question, "Have you had any major discomfort/irritation/redness/swelling caused any of the three samples?" | Participants with data collected at each timepoint. | Posted | | Count of Participants | | Participants | | Daily, days 1-7 | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Secondary | Overall Well-being as Measured by Daily Survey | Number of participants who responded "yes" to the question, "Were you able to successfully remove and reattach all three samples + Tegaderm (the clear adhesive) today?" | Participants with data collected at each timepoint. | Posted | | Count of Participants | | Participants | | Daily, days 1-6 | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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| Secondary | Overall Well-being as Measured by Daily Survey | Number of participants who responded "yes" to the question, "Were any of your samples removed for longer than 20 minutes at any point today?" | Participants with data collected at each timepoint. | Posted | | Count of Participants | | Participants | | Daily, days 1-7 | | | | ID | Title | Description |
|---|
| OG000 | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control | Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. |
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