Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

Keratosis, Actinic

Keratosis

Precancerous Conditions

Skin Diseases

Placebo

5% VDA-1102

10% VDA-1102

Chaim M Brickman, MD

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.

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.

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

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

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

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

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)

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).

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.

Vidac Pharma

Excipeint alone

Placebo: 200 mg applied once-daily for 28 days

Active study medication

5% VDA-1102: 200 mg applied once-daily for 28 days

Active study medication

10% VDA-1102: 200 mg applied once-daily for 28 days

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Israel

Region of Enrollment

Fitzpatrick skin types

Treatment field location

Max Herzberg

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

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

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

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)

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])

Spots Global Cancer Trial Database for topical ointment