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Topical Agent
Cohort 2 for Actinic Keratosis (Phase2b Trial)
Phase 2
Waitlist Available
Led By Mark G Lebwohl, MD
Research Sponsored by Vidac Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
Phase2b Trial 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.
Eligible Conditions
- Actinic Keratosis
Phase2b Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPhase2b Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Clearance Rate
Complete Facial Clearance Rate
Secondary outcome measures
Lesion Number Reduction
Lesion Number Reduction on Face
Partial Clearance
+1 morePhase2b Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
20% VDA-1102
Group II: Cohort 1Experimental Treatment1 Intervention
10% VDA-1102
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
20% VDA-1102
2018
Completed Phase 2
~90
10% VDA-1102
2016
Completed Phase 2
~180
Find a Location
Who is running the clinical trial?
Medistat Ltd., IsraelIndustry Sponsor
2 Previous Clinical Trials
112 Total Patients Enrolled
Vidac PharmaLead Sponsor
1 Previous Clinical Trials
93 Total Patients Enrolled
PharPoint Research, Inc.Industry Sponsor
6 Previous Clinical Trials
99 Total Patients Enrolled
Frequently Asked Questions
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