Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis (Phase2b)

Vidac Pharma

Status and phase

Completed

Phase 2

Conditions

Actinic Keratosis

Treatments

Drug: 10% VDA-1102

Drug: 20% VDA-1102

Study type

Interventional

Funder types

Industry

Identifiers

NCT03538951

VDA-CP-05

Details and patient eligibility

About

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.

Full 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").

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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