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

Study Overview
=================
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.

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

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: 5% VDA-1102
* Drug: 10% VDA-1102


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Excipeint alone | Drug: Placebo<br>* 200 mg applied once-daily for 28 days<br>* Other names: Matched-placebo;|
| Experimental: 5% VDA-1102<br>Active study medication | Drug: 5% VDA-1102<br>* 200 mg applied once-daily for 28 days<br>* Other names: 5% VDA-1102 topical dermal ointment;|
| Experimental: 10% VDA-1102<br>Active study medication | Drug: 10% VDA-1102<br>* 200 mg applied once-daily for 28 days<br>* Other names: 10% VDA-1102 topical dermal ointment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56 | To compare the reduction on Day 56 in the number of the actinic keratosis (AK) lesions in the Treatment Field of subjects receiving once-daily topical 5% or 10% VDA-1102 ointment for 28 days to the reduction in the number of AK lesions in subjects receiving placebo. | Baseline and day 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
topical ointment, skin, hexokinase, precancerous conditions, carcinoma, squamous cell