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

Phase 2

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Placebo; Drug: 5% VDA-1102; Drug: 10% VDA-1102

• Registration Number: NCT02844777
• Lead Sponsor: Vidac Pharma

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-06-29
• Study Start: 2016-07-15
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Primary Completion: 2017-05-26
• Study Completion: 2017-05-26
• Status Verified: 2021-05
• Results First Submitted: 2022-07-28
• Results First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Results First Posted: 2023-01-12
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Excipeint alone
5% VDA-1102	5% VDA-1102	Active study medication
10% VDA-1102	10% VDA-1102	Active study medication

Primary Outcome Measures

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

Trial Locations

Locations (1)

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States