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

• Status: Unknown status
• Trial end date: 2019-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vidac Pharma
• Collaborators: Medistat Ltd., Israel; PharPoint Research, Inc.; Therapeutics, Inc.

Criteria

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