Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ClinSearch | OTHER |
| SocraTec R&D GmbH | OTHER |
| SocraMetrics GmbH | INDUSTRY |
| CRM Biometrics GmbH |
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multi center, multiple dose, open label trial to evaluate the adhesion of TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare adhesion assessment methods.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TK-254RX applied to Lower Arm, Lower thigh or Ankle | Experimental | For Group1, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects. Day1: Lower Arm, Day2: Lower thigh, Day3: Ankle |
|
| TK-254RX applied to Upper Arm, Upper thigh or Lower leg | Experimental | For Group2, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects. Day1: Upper Arm, Day2: Upper thigh, Day3: Lower leg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TK-254RX | Drug | Two TK-254RX per day to predetermined application site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff | Assessment/estimation by site staff with marked TK-254RX by site staff: A listing of individual values of percentage will be presented per time point and subject. Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by site staff (percentage values). | 5 minutes prior to removal, |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of adhesion by visual estimation of subjects | Visual Assessment by subjects with a 5 point-scale: A listing of classification (≥90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached) of adhesion per time point and subject will be given. | before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The following must not apply:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenichi Nishiyama | Teikoku Seiyaku Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Practice Ebert | Brühl | Germany | ||||
| Medical practice Pabst |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| INDUSTRY |
| Clinigen Clinical Supplies Management GmbH | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects | Assessment/estimation by site staff with marked TK-254RX by subject: A listing of individual values of percentage will be presented per time point and subject. Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by subject (percentage values). | before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal |
| Comparison of the adhesion assessments between subjects and study staff | Three different adhesion assessments at 24hours as below will be performed. i. Visual assessment scale by subject ii. Assessment scale by site staff with marked TK-254RX by subject iii. Assessment scale by site staff with marked TK-254RX by site staff Comparison of i versus iii: the marked TK-254RX %-scale from iii are transformed into the 5-point scale (≥ 90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached); then the 5-point scale assessments from i and iii are compared via 5x5-cross tabulations and Spearman rank correlations. Comparison of ii versus iii: the marked TK-254RX %-scale from ii and iii are transformed into the 5-point scale (≥ 90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached); then the 5-point scale assessments from ii and iii are compared via 5x5-cross tabulations and Spearman rank correlations. | 5minutes prior to removal |
| Characterization of local tolerability during treatment | The skin will be visually checked and palpated for skin irritation or sensitization by trained personnel. Local tolerability will be assessed by the Investigator according to FDA recommendations. | within 5 minutes after removal of each patch |
| Fürstenfeldbruck |
| Germany |
| Medical practice Gastl | Gilching | Germany |
| Medical Pracitice Schaale/Bücheler | Rheinbach | Germany |