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

Actinic Keratosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844777
• Other study ID #: VDA-CP-03
• Status: Completed
• Phase: Phase 2
• Start date: July 15, 2016
• Est. completion date: May 26, 2017

Study information

• Verified date: May 2021
• Source: Vidac Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Placebo
200 mg applied once-daily for 28 days
• 5% VDA-1102
200 mg applied once-daily for 28 days
• 10% VDA-1102
200 mg applied once-daily for 28 days

Locations

Country	Name	City	State
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Vidac Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Patients With Complete Clearance of Actinic Keratosis Lesions in the Treatment Field	The percentage of subjects achieving complete clearance of AK lesions within the Treatment Field on Day 56.	Baseline and Day 56
Other	Change From Baseline in the Number of AK Lesions Within the Treatment Field of Each Subject on Day 84.	To compare the reduction on Day 84 in the number of the actinic keratosis lesions	Baseline and day 84
Other	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 (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)	Baseline and day 56
Other	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])	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).	Baseline and day 56
Primary	Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on 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.	Baseline and day 56