Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

NCT ID: NCT03538951

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2018-12-10

Brief Summary

This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.

Detailed Description

This Phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of VDA-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. The first 40 eligible subjects will be enrolled into Cohort 1 (Part A). Cohort 1 subjects will be assigned to receive approximately 200 mg of 10% VDA-1102 twice-daily (BID). Once approximately 40 subjects have been enrolled in Cohort 1, Cohort 1 will be closed to enrollment and Cohort 2 (Part B) will be opened for enrollment. Cohort 2 subjects will be assigned to receive approximately 200 mg of 20% VDA-1102 once-daily (QD). Once approximately 40 subjects have been enrolled in Cohort 2, an additional 70 subjects will be randomly assigned to Cohort 1 or Cohort 2 (Part C) in a 1:1 ratio.

To qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (AK) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the "Treatment Field").

Conditions

Actinic Keratosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

10% VDA-1102

Group Type: EXPERIMENTAL

10% VDA-1102

Intervention Type: DRUG

200 mg twice-daily for 12 weeks

Cohort 2

20% VDA-1102

Group Type: EXPERIMENTAL

20% VDA-1102

Intervention Type: DRUG

200 mg once-daily for 12 weeks

Interventions

10% VDA-1102

200 mg twice-daily for 12 weeks

Intervention Type: DRUG

20% VDA-1102

200 mg once-daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

10% VDA-1102 topical ointment; 20% VDA-1102 topical ointment

Eligibility Criteria

Inclusion Criteria

• 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp

Exclusion Criteria

• Subject has no clinically significant findings at Baseline
• Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline
• Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem
• Subject has at any time been given a diagnosis or treatment associated with immunosuppression
• Subject has received VDA-1102 in the past

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

PharPoint Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Medistat Ltd., Israel

INDUSTRY

Sponsor Role: collaborator

Vidac Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark G Lebwohl, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Therapeutics Clinical Research

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VDA-CP-05

Identifier Type: -

Identifier Source: org_study_id