Actinic Keratosis
Conditions
Keywords
actinic keratosis, efficacy, safety, VDA-1102
Brief summary
This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.
Detailed description
This Phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of VDA-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. The first 40 eligible subjects will be enrolled into Cohort 1 (Part A). Cohort 1 subjects will be assigned to receive approximately 200 mg of 10% VDA-1102 twice-daily (BID). Once approximately 40 subjects have been enrolled in Cohort 1, Cohort 1 will be closed to enrollment and Cohort 2 (Part B) will be opened for enrollment. Cohort 2 subjects will be assigned to receive approximately 200 mg of 20% VDA-1102 once-daily (QD). Once approximately 40 subjects have been enrolled in Cohort 2, an additional 70 subjects will be randomly assigned to Cohort 1 or Cohort 2 (Part C) in a 1:1 ratio. To qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (AK) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the Treatment Field).
Interventions
DRUG10% VDA-1102
200 mg twice-daily for 12 weeks
DRUG20% VDA-1102
200 mg once-daily for 12 weeks
Sponsors
Therapeutics, Inc.
PharPoint Research, Inc.
Medistat Ltd., Israel
Vidac Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3-part, open-label, multi-center study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp
Exclusion criteria
* Subject has no clinically significant findings at Baseline * Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline * Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem * Subject has at any time been given a diagnosis or treatment associated with immunosuppression * Subject has received VDA-1102 in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Clearance Rate | Week 16 | 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 |
| Complete Facial Clearance Rate | Week 16 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Number Reduction | 16 weeks | Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm |
| Partial Facial Clearance | 16 weeks | 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 |
| Partial Clearance | 16 weeks | 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 |
| Lesion Number Reduction on Face | 16 weeks | Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 10% VDA-1102
10% VDA-1102: 200 mg twice-daily for 12 weeks | 41 |
| Cohort 2 20% VDA-1102
20% VDA-1102: 200 mg once-daily for 12 weeks | 42 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Cohort 2 | Total | Cohort 1 |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 9.2 | 66.4 years STANDARD_DEVIATION 8.3 | 66.5 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 83 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 83 Participants | 41 Participants |
| Sex: Female, Male Female | 9 Participants | 15 Participants | 6 Participants |
| Sex: Female, Male Male | 33 Participants | 68 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 42 |
| other Total, other adverse events | 10 / 41 | 10 / 42 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 |
Outcome results
Primary
Complete Clearance Rate
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
Time frame: Week 16
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Complete Clearance Rate | 7 Participants |
| Cohort 2 | Complete Clearance Rate | 9 Participants |
Primary
Complete Facial Clearance Rate
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
Time frame: Week 16
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Complete Facial Clearance Rate | 5 Participants |
| Cohort 2 | Complete Facial Clearance Rate | 8 Participants |
Secondary
Lesion Number Reduction
Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm
Time frame: 16 weeks
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Lesion Number Reduction | -46.00 percentage of change from baseline | Standard Deviation 36.47 |
| Cohort 2 | Lesion Number Reduction | -52.66 percentage of change from baseline | Standard Deviation 37.31 |
Secondary
Lesion Number Reduction on Face
Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm
Time frame: 16 weeks
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Lesion Number Reduction on Face | -48.51 Percentage of change from baseline | Standard Deviation 37.35 |
| Cohort 2 | Lesion Number Reduction on Face | -62.42 Percentage of change from baseline | Standard Deviation 34.02 |
Secondary
Partial Clearance
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
Time frame: 16 weeks
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Partial Clearance | 12 Participants |
| Cohort 2 | Partial Clearance | 14 Participants |
Secondary
Partial Facial Clearance
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
Time frame: 16 weeks
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Partial Facial Clearance | 8 Participants |
| Cohort 2 | Partial Facial Clearance | 13 Participants |
Post Hoc
Complete Clearance in Patients With Local Skin Reaction- Erythema
Erythema (score=0 or score \>0) week 8 100% clearance week 16 (Face and Scalp)
Time frame: Week 16
Population: Data analyzed by patients with erythema score =0 or \> 0
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema score = 0 | Complete clearance | 2 Participants |
| Cohort 1 | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema score = 0 | No complete clearance | 21 Participants |
| Cohort 1 | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema score > 0 | Complete clearance | 5 Participants |
| Cohort 1 | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema score > 0 | No complete clearance | 12 Participants |
| Cohort 2 | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema score > 0 | No complete clearance | 5 Participants |
| Cohort 2 | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema score = 0 | Complete clearance | 4 Participants |
| Cohort 2 | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema score > 0 | Complete clearance | 6 Participants |
| Cohort 2 | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema score = 0 | No complete clearance | 24 Participants |
Post Hoc
Lesion Reduction in Patients With Local Skin Reaction- Erythema
Erythema (score=0 or score \>0) week 8 75% clearance week 16 (Face and Scalp)
Time frame: Week 16
Population: Data no analyzed for cohort 1 (10% VDA-1102)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema score=0 | 75% lesion reduction | 0 Participants |
| Cohort 1 | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema score >0 | 75% lesion reduction | 0 Participants |
| Cohort 1 | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema score=0 | Less than 75% lesion reduction | 0 Participants |
| Cohort 1 | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema score >0 | Less than 75% lesion reduction | 0 Participants |
| Cohort 2 | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema score=0 | Less than 75% lesion reduction | 23 Participants |
| Cohort 2 | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema score=0 | 75% lesion reduction | 5 Participants |
| Cohort 2 | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema score >0 | Less than 75% lesion reduction | 3 Participants |
| Cohort 2 | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema score >0 | 75% lesion reduction | 6 Participants |