Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis (NCT NCT03538951)
NCT ID: NCT03538951
Last Updated: 2022-08-23
Results Overview
Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Week 16
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
Cohort 1
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Cohort 1
n=41 Participants
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=42 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: mITT
Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm
Outcome measures
| Measure |
Cohort 1
n=40 Participants
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=40 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Complete Clearance Rate
|
7 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: mITT
Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm
Outcome measures
| Measure |
Cohort 1
n=26 Participants
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=29 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Complete Facial Clearance Rate
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: mITT
Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of AK lesions in the selected area of subjects of subjects in each treatment arm
Outcome measures
| Measure |
Cohort 1
n=40 Participants
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=40 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Partial Clearance
|
12 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: mITT
Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of facial AK lesions in the selected area of subjects in each treatment arm
Outcome measures
| Measure |
Cohort 1
n=26 Participants
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=29 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Partial Facial Clearance
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: mITT
Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm
Outcome measures
| Measure |
Cohort 1
n=40 Participants
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=40 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Lesion Number Reduction
|
-46.00 percentage of change from baseline
Standard Deviation 36.47
|
-52.66 percentage of change from baseline
Standard Deviation 37.31
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: mITT
Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm
Outcome measures
| Measure |
Cohort 1
n=26 Participants
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=29 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Lesion Number Reduction on Face
|
-48.51 Percentage of change from baseline
Standard Deviation 37.35
|
-62.42 Percentage of change from baseline
Standard Deviation 34.02
|
POST_HOC outcome
Timeframe: Week 16Population: Data analyzed by patients with erythema score =0 or \> 0
Erythema (score=0 or score \>0) week 8 100% clearance week 16 (Face and Scalp)
Outcome measures
| Measure |
Cohort 1
n=40 Participants
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=39 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Complete Clearance in Patients With Local Skin Reaction- Erythema
Erythema score = 0 · Complete clearance
|
2 Participants
|
4 Participants
|
|
Complete Clearance in Patients With Local Skin Reaction- Erythema
Erythema score = 0 · No complete clearance
|
21 Participants
|
24 Participants
|
|
Complete Clearance in Patients With Local Skin Reaction- Erythema
Erythema score > 0 · Complete clearance
|
5 Participants
|
6 Participants
|
|
Complete Clearance in Patients With Local Skin Reaction- Erythema
Erythema score > 0 · No complete clearance
|
12 Participants
|
5 Participants
|
POST_HOC outcome
Timeframe: Week 16Population: Data no analyzed for cohort 1 (10% VDA-1102)
Erythema (score=0 or score \>0) week 8 75% clearance week 16 (Face and Scalp)
Outcome measures
| Measure |
Cohort 1
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=37 Participants
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Lesion Reduction in Patients With Local Skin Reaction- Erythema
Erythema score=0 · Less than 75% lesion reduction
|
0 Participants
|
23 Participants
|
|
Lesion Reduction in Patients With Local Skin Reaction- Erythema
Erythema score=0 · 75% lesion reduction
|
0 Participants
|
5 Participants
|
|
Lesion Reduction in Patients With Local Skin Reaction- Erythema
Erythema score >0 · 75% lesion reduction
|
0 Participants
|
6 Participants
|
|
Lesion Reduction in Patients With Local Skin Reaction- Erythema
Erythema score >0 · Less than 75% lesion reduction
|
0 Participants
|
3 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=41 participants at risk
10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks
|
Cohort 2
n=42 participants at risk
20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
24.4%
10/41 • Number of events 14 • From screening until week 16
|
23.8%
10/42 • Number of events 13 • From screening until week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place