Clinical trial NCT03538951: Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Official title: Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: actinic keratosis
efficacy
safety
VDA-1102
Lead sponsor: Vidac Pharma
Sponsor class: INDUSTRY
Collaborators: name: Therapeutics, Inc.
name: PharPoint Research, Inc.
name: Medistat Ltd., Israel
First posted: 2018-05-29
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 3-part, open-label, multi-center study
Primary purpose: TREATMENT

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").

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

Primary outcomes:
measure: Complete Clearance Rate
timeFrame: Week 16
measure: Complete Facial Clearance Rate
timeFrame: Week 16
Secondary outcomes:
measure: Partial Clearance
timeFrame: 16 weeks
measure: Partial Facial Clearance
timeFrame: 16 weeks
measure: Lesion Number Reduction
timeFrame: 16 weeks
measure: Lesion Number Reduction on Face
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mark G Lebwohl, MD
role: PRINCIPAL_INVESTIGATOR
References: