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

NCT03538951 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-08-23

Study results available
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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

Interventions

DRUG

10% VDA-1102

200 mg twice-daily for 12 weeks

DRUG

20% VDA-1102

200 mg once-daily for 12 weeks

Sponsors & Collaborators

  • Therapeutics, Inc.

    collaborator INDUSTRY

  • PharPoint Research, Inc.

    collaborator INDUSTRY

  • Medistat Ltd., Israel

    collaborator INDUSTRY

  • Vidac Pharma

    lead INDUSTRY

Principal Investigators

  • Mark G Lebwohl, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-23
Primary Completion
2018-12-10
Completion
2018-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03538951 on ClinicalTrials.gov