Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

Phase 2

Completed

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").

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Cohort 1	10% VDA-1102	10% VDA-1102
Cohort 2	20% VDA-1102	20% VDA-1102

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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