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The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine Patch (Sequence ABC) | Experimental | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied in Period 1, and 3 lidocaine 5% patches were applied in Period 2, and 3 lidocaine 5% medicated plasters were applied in Period 3. |
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| Lidocaine Patch (Sequence CAB) | Experimental | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 2, 3 lidocaine 5% medicated plasters were applied in Period 1, and 3 lidocaine 1.8% patches were applied in Period 2, and 3 lidocaine 5% patches were applied in Period 3. |
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| Lidocaine Patch (Sequences BCA) | Experimental | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 3, 3 lidocaine 5% patches were applied in Period 1, and 3 lidocaine 5% medicated plasters were applied in Period 2, and 3 lidocaine 1.8% patches were applied in Period 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch 1.8% | Drug | Three patches are applied to the subject's back for 12 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Adhesion Score (FDA scale) | Adhesion of the product to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% Adhered (less than half of the patch lifting off the skin), > 0% to < 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations. | 12 hours post-dose |
| Mean Adhesion Score (EMA scale) | Adhesion of the product to the skin is assessed by the EMA 0-6 scoring system. The scoring for adhesion is indicated as follows: 0 = < 70% Adhered, 1 = > 70% Adhered, 2 = > 75% Adhered, 3 = > 80% Adhered, 4 = > 85% Adhered, 5 = > 90% adhered, and 6 = > 95% Adhered. Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations. | 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Dermal Response Score | Product tolerability is assessed by Dermal Response Score. The application site is evaluated 30 minutes and 2 hours after product removal (12.5 and 14 hours post-dose, respectively). Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test (i.e., application) site. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip LaStella, MD | TKL Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research, Inc. | Fair Lawn | New Jersey | 07410 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33654425 | Derived | Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021. |
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| Lidocaine patch 5% | Drug | Three patches are applied to the subject's back for 12 hours. |
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| Lidocaine medicated plaster 5% | Drug | Three plasters are applied to the subject's back for 12 hours. |
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| 12.5 and 14 hours post-dose |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C511998 | Lidoderm |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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