Back to results

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

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

5% VDA-1102

10% VDA-1102

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring topical ointment, skin, hexokinase, precancerous conditions, carcinoma, squamous cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Therapeutics Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

5% VDA-1102

10% VDA-1102

Arm Description

Excipeint alone

Active study medication

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02844777

First Posted

June 29, 2016

Last Updated

December 20, 2022

Sponsor

Vidac Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02844777

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 15, 2016 (Actual)

Primary Completion Date

May 26, 2017 (Actual)

Study Completion Date

May 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vidac Pharma

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

topical ointment, skin, hexokinase, precancerous conditions, carcinoma, squamous cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Excipeint alone

Arm Title

5% VDA-1102

Arm Type

Experimental

Arm Description

Active study medication

Arm Title

10% VDA-1102

Arm Type

Experimental

Arm Description

Active study medication

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Excipients alone, Matched-placebo

Intervention Description

200 mg applied once-daily for 28 days

Intervention Type

Drug

Intervention Name(s)

5% VDA-1102

Other Intervention Name(s)

5% VDA-1102 topical dermal ointment

Intervention Description

200 mg applied once-daily for 28 days

Intervention Type

Drug

Intervention Name(s)

10% VDA-1102

Other Intervention Name(s)

10% VDA-1102 topical dermal ointment

Intervention Description

200 mg applied once-daily for 28 days

Primary Outcome Measure Information:

Title

Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56

Description

Time Frame

Baseline and day 56

Other Pre-specified Outcome Measures:

Title

Percentage of Patients With Complete Clearance of Actinic Keratosis Lesions in the Treatment Field

Description

The percentage of subjects achieving complete clearance of AK lesions within the Treatment Field on Day 56.

Time Frame

Baseline and Day 56

Title

Change From Baseline in the Number of AK Lesions Within the Treatment Field of Each Subject on Day 84.

Description

To compare the reduction on Day 84 in the number of the actinic keratosis lesions

Time Frame

Baseline and day 84

Title

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)

Description

Change from Baseline (Day 1 Pre-dose) in Sub-group of Subjects with at least one Grade 2 Lesion at Baseline (from ITT Population)in the number of grade ≥ 2 lesions. Grade 2 defined as: moderate (moderately thick AK that are easily seen and felt)

Time Frame

Baseline and day 56

Title

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])

Description

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]) Grade 1 - mild (slightly palpable AK that are felt better than seen) Grade 2 - moderate (moderately thick AK that are easily seen and felt) Grade 3 - severe (very thick and/or obvious AK).

Time Frame

Baseline and day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chaim M Brickman, MD

Organizational Affiliation

Vidac Pharma

Official's Role

Study Director

Facility Information:

Facility Name

Therapeutics Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be shared.

Learn more about this trial

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

We'll reach out to this number within 24 hrs