Clinical trial NCT02844777: Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: topical ointment
skin
hexokinase
precancerous conditions
carcinoma, squamous cell
Lead sponsor: Vidac Pharma
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Main Inclusion Criteria:

* Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a single 25 square centimeter area of skin on their scalp or face

Main Exclusion Criteria:

* Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the study, or (d) fertile and they or their fertile partner is unable or unwilling to use the required contraceptive methods
* Subject is immunosuppressed
* Subject has used any of the following topical treatments in the Treatment Field: (1) topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or other topical treatments for AK or that might impact AK within 12 weeks of Screening.
* Subject has used systemic retinoid therapy within 6 months of Screening Visit.

Primary outcomes:
measure: Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56
timeFrame: Baseline and day 56
Secondary outcomes:
Other outcomes:
measure: Percentage of Patients With Complete Clearance of Actinic Keratosis Lesions in the Treatment Field
timeFrame: Baseline and Day 56
measure: Change From Baseline in the Number of AK Lesions Within the Treatment Field of Each Subject on Day 84.
timeFrame: Baseline and day 84
measure: AK Grade 2 Lesions Number: Change From Baseline (Day 1 Pre-dose) in Sub-group of Subjects With at Least One Grade 2 Lesion at Baseline (From ITT Population)
timeFrame: Baseline and day 56
measure: Change From Baseline in the Adjusted Number of Lesions Weighted by Grade ([Number of Grade 1 Lesions] + [2× Number of Grade 2 Lesions] + [3× Number of Grade 3 Lesions])
timeFrame: Baseline and day 56
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
Study officials:
affiliation: Vidac Pharma
name: Chaim M Brickman, MD
role: STUDY_DIRECTOR
References: