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

Sponsor

Vidac Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT02844777

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratosis	Drug: Placebo Drug: 5% VDA-1102 Drug: 10% VDA-1102	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

93 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 15, 2016

Actual Primary Completion Date :

May 26, 2017

Actual Study Completion Date :

May 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Excipeint alone	Drug: Placebo 200 mg applied once-daily for 28 days Other Names: Excipients alone Matched-placebo
Experimental: 5% VDA-1102 Active study medication	Drug: 5% VDA-1102 200 mg applied once-daily for 28 days Other Names: 5% VDA-1102 topical dermal ointment
Experimental: 10% VDA-1102 Active study medication	Drug: 10% VDA-1102 200 mg applied once-daily for 28 days Other Names: 10% VDA-1102 topical dermal ointment

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Excipeint alone

Drug: Placebo

200 mg applied once-daily for 28 days

Other Names:

Excipients alone

Matched-placebo

Experimental: 5% VDA-1102

Active study medication

Drug: 5% VDA-1102

200 mg applied once-daily for 28 days

Other Names:

5% VDA-1102 topical dermal ointment

Experimental: 10% VDA-1102

Active study medication

Drug: 10% VDA-1102

200 mg applied once-daily for 28 days

Other Names:

10% VDA-1102 topical dermal ointment

Outcome Measures

Primary Outcome Measures

Number of actinic keratosis lesions in the Treatment Field [56 days]
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.

Secondary Outcome Measures

Number and percent of subjects with adverse events (AEs) and treatment emergent AEs. [Baseline and Days 7, 14, 28, 35, and 56.]
The incidence of AEs, as well as the intensity and relationship to study drug will be summarized by treatment group.
Physical examinations [Baseline and Days 7, 14, 28, 35 and 56.]
Abnormal findings will be listed per treatment group.
Vital signs - systolic and diastolic blood pressures [Baseline and Days 7, 14, 28, and 35.]
These continuous variables (mm Hg) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
Vital signs - heart rate [Baseline and Days 7, 14, 28, and 35.]
These continuous variables (beats per minute) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
Vital signs - temperature [Baseline and Days 7, 14, 28, and 35.]
These continuous variables (degrees Centigrade) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
Vital signs - respiratory rate [Baseline and Days 7, 14, 28, and 35.]
These continuous variables (breaths per minute) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
Local Skin Reaction Scores [Baseline and Days 7, 14, 28, and 35.]
These continuous variables will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
Clinical laboratory test results [Baseline and Days 7, 14, 28, and 35.]
These continuous variables (Standardized International Units) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
12-lead electrocardiographic data - RR intervals [Baseline and Days 7, 14, 28, and 35.]
These continuous variables (milliseconds) will be described as the mean, median, standard deviation, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
12-lead electrocardiographic data - Heart Rates [Baseline and Days 7, 14, 28, and 35.]
These continuous variables (beats per minute) will be described as the mean, median, standard deviation, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
12-lead electrocardiographic data - PR, QRS, QT, QTcF, and QTcB intervals [Baseline and Days 7, 14, 28, and 35.]
These continuous variables (milliseconds) will be described as the mean, median, standard deviation, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
12-lead electrocardiographic data - Abnormal tracing interpretations [Baseline and Days 7, 14, 28, and 35.]
These categorical data (i.e., abnormal / normal) will be described with contingency tables including frequency and percent. These findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.
Withdrawals [Baseline through Day 56.]
The number of subjects withdrawn per treatment group due to adverse events will be summarized.
Plasma Concentration (C) of VDA-1102 [Baseline and Days 7, 14, 28, and 35.]
Plasma Concentration (C) of VDA-1102 will be measures at a single time point on Days 7, 14, 28 and 35 approximately 12 hours post dose. In addition, on Day 28 samples will be drawn at approximately 15, 18, and 21 hours post dose as well.
Plasma Concentration (C) of main VDA-1102 metabolite [Baseline and Days 7, 14, 28, and 35.]
Plasma Concentration (C) of the main VDA-1102 metabolite will be measures at a single time point on Days 7, 14, 28 and 35 approximately 12 hours post dose. In addition, on Day 28 samples will be drawn at approximately 15, 18, and 21 hours post dose as well.

Other Outcome Measures

Complete clearance of actinic keratosis lesions in the Treatment Field [Baseline and Day 56]
The percentage of subjects achieving complete clearance of AK lesions within the Treatment Field on Day 56.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.