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NCT Number: NCT02844777

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

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.

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Key information

Conditions

Actinic Keratosis Carcinoma Carcinoma, Squamous Cell Keratosis Keratosis, Actinic Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Therapeutics Clinical Research

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a single 25 square centimeter area of skin on their scalp or face

Main Exclusion Criteria:

  • Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the study, or (d) fertile and they or their fertile partner is unable or unwilling to use the required contraceptive methods
  • Subject is immunosuppressed
  • Subject has used any of the following topical treatments in the Treatment Field: (1) topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or other topical treatments for AK or that might impact AK within 12 weeks of Screening.
  • Subject has used systemic retinoid therapy within 6 months of Screening Visit.

Treatment and study plan

Placebo

Drug

200 mg applied once-daily for 28 days

Other names: Excipients alone, Matched-placebo

5% VDA-1102

Drug

200 mg applied once-daily for 28 days

Other names: 5% VDA-1102 topical dermal ointment

10% VDA-1102

Drug

200 mg applied once-daily for 28 days

Other names: 10% VDA-1102 topical dermal ointment

Primary outcomes

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

    Time frame: Baseline and day 56

    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.

Other outcomes

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

    Time frame: Baseline and Day 56

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

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

    Time frame: Baseline and day 84

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

  3. 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)

    Time frame: Baseline and day 56

    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)

  4. 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])

    Time frame: Baseline and day 56

    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).

Sponsors and collaborators

Lead sponsor

Vidac Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2016
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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