Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percent Change From Baseline in Lesion Count at Day 57 |
Percentage change from baseline in the AK lesion count will be assessed. |
Baseline, Day 57 |
|
Secondary |
Proportion of Participants With Partial Clearance (PC) at Day 57 |
PC is defined as proportion of participants achieving more than or equal to (>=) 75 percent (%) clearance of AK lesions in the TF on the face or scalp at Day 57. |
At Day 57 |
|
Secondary |
Proportion of Participants With Complete Clearance (CC) at Day 57 |
CC is defined as proportion of participants achieving 100 percent clearance of AK lesions in the TF on the face or scalp at Day 57. |
At Day 57 |
|
Secondary |
Proportion of Participants With Partial Clearance (PC) by Day 113 |
|
Baseline up to Day 113 |
|
Secondary |
Proportion of Participants With Complete Clearance (CC) by Day 113 |
|
Baseline up to Day 113 |
|
Secondary |
Total Number of Lesions per Participant in the TF at Specific Timepoints |
|
Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Percent Change From Baseline in lesion count in the TF at Specific Timepoints |
|
Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Number of New Lesions per Participant in the TF at Specific Timepoints |
Number of new lesions that are not present at baseline, occurring per participant in the TF at specific timepoints will be assessed. |
At Day 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Number of Baseline Lesions per Participant Present in the TF at Specific Timepoints |
Number of lesions per participant in the TF at specific timepoints will be assessed. |
Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Change From Baseline in Skindex-16 Questionnaire Overall Score and Domain Scores (Symptoms, Emotions, and Functioning) at Day 57 |
Skindex-16 is used for participants to rate skin conditions that have occurred within the previous week. It is a short 16-item patient-completed assessment that are classified into three domains: symptoms [four items, 1-4], emotions, [seven items, 5-11] and functioning [five items, 12-16]. All items are scored on a seven-point numerical analogue scales (0=never bothered to 6=always bothered). Each item is then transformed to a linear scale from 0 (never bothered) to 100 (always bothered), where higher the score = more severe in impairment. The total score is the average of all 16 items scores ranging from 0 [best Health Related Quality of Life (HRQoL)] to 96 (worst HRQoL), where higher score indicates worst quality of life. |
Baseline, Day 57 |
|
Secondary |
Change from Baseline in Skindex-16 Questionnaire Overall Score and Domain Scores (Symptoms, Emotions, and Functioning) at Day 113 in Participants who Receive 2 Treatment Courses |
Skindex-16 is used for participants to rate skin conditions that have occurred within the previous week. It is a short 16-item patient-completed assessment that are classified into three domains: symptoms [four items, 1-4], emotions, [seven items, 5-11] and functioning [five items, 12-16]. All items are scored on a seven-point numerical analogue scales (0=never bothered to 6=always bothered). Each item is then transformed to a linear scale from 0 (never bothered) to 100 (always bothered), where higher the score = more severe in impairment. The total score is the average of all 16 items scores ranging from 0 [best Health Related Quality of Life (HRQoL)] to 96 (worst HRQoL), where higher score indicates worst quality of life. |
Baseline, Day 113 |
|
Secondary |
Cosmetic Outcome as Assessed by the Participant at Day 57 |
Cosmetic Outcome is rated on a 4-point scale as excellent (no or mild redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight-to-moderate scarring, atrophy, or induration), and poor (extensive scarring, atrophy, or induration). |
At Day 57 |
|
Secondary |
Cosmetic Outcome as Assessed by the Investigator at Day 57 |
Cosmetic Outcome is rated on a 4-point scale as excellent (no or mild redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight-to-moderate scarring, atrophy, or induration), and poor (extensive scarring, atrophy, or induration). |
At Day 57 |
|
Secondary |
Cosmetic Outcome in Participants who Receive 2 Treatment Courses, as Assessed by Participants at Day 113 |
Cosmetic Outcome is rated on a 4-point scale as excellent (no or mild redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight-to-moderate scarring, atrophy, or induration), and poor (extensive scarring, atrophy, or induration). |
At Day 113 |
|
Secondary |
Cosmetic Outcome in Participants who Receive 2 Treatment Courses, as Assessed by Investigator at Day 113 |
Cosmetic Outcome is rated on a 4-point scale as excellent (no or mild redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight-to-moderate scarring, atrophy, or induration), and poor (extensive scarring, atrophy, or induration). |
At Day 113 |
|
Secondary |
Treatment Satisfaction Questionnaire for Medications (TSQM) Transformed Total Scores at Day 57 |
The TSQM-14 is a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction. |
At Day 57 |
|
Secondary |
TSQM Transformed Scores in Participants who Receive 2 Treatment Courses at Day 113 |
The TSQM-14 is a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction. |
At Day 113 |
|
Secondary |
Local Tolerability Score at Specific Timepoints for Each Individual Sign |
Local tolerability score is evaluated by the investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication is applied. These symptoms are assessed by using a 4-point scale of 0-3, where 0 (absent) and 3 (severe). The higher score indicates severe symptoms. |
At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Maximum Local Tolerability Score in Treatment Course for Each Individual Sign |
Maximum local tolerability score by treatment course for each individual sign (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. Local tolerability score for each signs are assessed by using a 4 - point scale of 0 - 3, where 0 = none and 3 = severe. The higher score indicates severe symptoms. |
At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Time to Maximum Local Tolerability Score Observed in Treatment Course for Each Individual Sign |
Time to maximum local tolerability score for erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration will be assessed. Maximum local tolerability score by treatment course for each individual sign (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. Local tolerability score for each signs are assessed by using a 4 - point scale of 0 - 3, where 0 = none and 3 = severe. The higher score indicates severe symptoms. |
At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Local Tolerability Signs Composite Score at Specific Timepoints |
Local tolerability signs composite score (0-18) at Specific Timepoints, defined as the sum of the scores graded from 0 (none) to 3 (severe) on all six individual tolerability sign categories (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. The higher score indicates severe symptoms. |
At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Maximum Local tolerability Signs Composite Score in Treatment Course |
Maximum local tolerability signs composite score (0-18) in treatment course, defined as the sum of the scores graded from 0 (none) to 3 (severe) on all six individual tolerability sign categories (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. The higher score indicates severe symptoms. |
At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Time to Maximum Local Tolerability Signs Composite Score Observed in Treatment Course |
Time to maximum local tolerability signs composite score is observed in treatment course for each individual sign (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. Maximum local tolerability signs composite score (0-18) in treatment course, defined as the sum of the scores graded from 0 (none) to 3 (severe) on all six individual tolerability sign categories (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) will be assessed. The higher score indicates severe symptoms. |
At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Number of Participants Showing Changes in Pigmentation and Scarring in the TF at Specific Timepoints |
Absence or presence of pigmentation (that is, hypopigmentation and hyperpigmentation) and scarring in the TF will be assessed. |
At Day 1, 8, 15, 29, 57, 64, 71, 85, and 113 |
|
Secondary |
Number of Participants With Adverse Event (AE), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs) |
An AE is defined as any untoward medical occurrence in a clinical trial participant, regardless of the administration of the IMP and its causal relationship to it. unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, or an abnormal finding in the physical examination. An SAE is any untoward medical occurrence that at any dose resulted in death; is life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in participant hospitalization; is congenital anomaly/birth defect or otherwise considered medically important. AESIs included skin cancers [including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma] appearing within or outside the TF during the study. |
From Screening up to Day 113 |
|
Secondary |
Number of Participants With Clinically Significant Laboratory Abnormalities |
Number of participants with clinically significant laboratory abnormalities (included hematology, blood chemistry and urinalysis) will be assessed. Clinically Significant Abnormal values will be determined by the investigator. |
From Screening up to Day 113 |
|
Secondary |
Number of Participants With Vital Signs Abnormalities |
Number of participants with vital signs (including measurement of systolic and diastolic blood pressure, heart rate, respiratory rate, and tympanic temperature) will be assessed. Abnormal values will be determined by the investigator. |
From Screening up to Day 113 |
|