NCT02844777

Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis

Randomized, Double-Blind, Placebo-Controlled, Parallel-Cohort Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Once-Daily Application of Topical VDA-1102 Ointment for 28 Days in Subjects With Actinic Keratosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Vidac Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled, multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult subjects.

Detailed description

Approximately 84 subjects who meet the study's enrollment criteria at the completion of the Screening Period will be randomized to receive 5% or 10% VDA-1102, or matched-placebo. During the Treatment Period, study drug will be applied once-daily for 28 days to a 25 square centimeter area of skin containing 4-8 actinic keratosis lesions on the face or scalp. Subjects will be followed for an additional 28 days (Observation Period) wherein no study drug will be applied. The purpose of the study is to determine whether once-daily application of VDA-1102 ointment for 28 days is effective and well-tolerated in the treatment of actinic keratosis of the face and scalp.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Placebo	200 mg applied once-daily for 28 days
DRUG	5% VDA-1102	200 mg applied once-daily for 28 days
DRUG	10% VDA-1102	200 mg applied once-daily for 28 days

Timeline

• Start date: 2016-07-15
• Primary completion: 2017-05-26
• Completion: 2017-05-26
• First posted: 2016-07-26
• Last updated: 2023-01-12
• Results posted: 2023-01-12

Locations

1 site across 1 country: United States