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

NCT03538951 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VDA-CP-05
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Keywords

actinic keratosis; efficacy; safety; VDA-1102

Outcome Measures

Primary Outcomes (2)

• Complete Clearance Rate

  Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm

  Week 16

• Complete Facial Clearance Rate

  Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm

  Week 16

Secondary Outcomes (4)

• Partial Clearance

  16 weeks

• Partial Facial Clearance

  16 weeks

• Lesion Number Reduction

  16 weeks

• Lesion Number Reduction on Face

  16 weeks

Study Arms (2)

Cohort 1

EXPERIMENTAL

10% VDA-1102

Drug: 10% VDA-1102

Cohort 2

EXPERIMENTAL

20% VDA-1102

Drug: 20% VDA-1102

Interventions

10% VDA-1102 DRUG

200 mg twice-daily for 12 weeks

Also known as: 10% VDA-1102 topical ointment

Cohort 1

20% VDA-1102 DRUG

200 mg once-daily for 12 weeks

Also known as: 20% VDA-1102 topical ointment

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vidac Pharma: lead
• Therapeutics, Inc.: collaborator
• PharPoint Research, Inc.: collaborator
• Medistat Ltd., Israel: collaborator

Study Sites (1)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Max Herzberg
• Organization: Vidac Pharma

maxherzberg@gmail.com

0544257381

Study Officials

• Mark G Lebwohl, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3-part, open-label, multi-center study

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: May 29, 2018
• Study Start: May 23, 2018
• Primary Completion: December 10, 2018
• Study Completion: December 10, 2018
• Last Updated: August 23, 2022
• Results First Posted: August 23, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)