NCT02844777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

July 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2017

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

January 12, 2023

Completed
Last Updated

January 12, 2023

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

June 29, 2016

Results QC Date

July 28, 2022

Last Update Submit

December 20, 2022

Conditions

Actinic Keratosis

Keywords

topical ointmentskinhexokinaseprecancerous conditionscarcinoma, squamous cell

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (4)

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

    Baseline and Day 56

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

    Baseline and 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)

    Baseline and day 56

  • +1 more other outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Excipeint alone

Drug: Placebo

5% VDA-1102

EXPERIMENTAL

Active study medication

Drug: 5% VDA-1102

10% VDA-1102

EXPERIMENTAL

Active study medication

Drug: 10% VDA-1102

Interventions

PlaceboDRUG

200 mg applied once-daily for 28 days

Also known as: Excipients alone, Matched-placebo
Placebo
5% VDA-1102DRUG

200 mg applied once-daily for 28 days

Also known as: 5% VDA-1102 topical dermal ointment
5% VDA-1102
10% VDA-1102DRUG

200 mg applied once-daily for 28 days

Also known as: 10% VDA-1102 topical dermal ointment
10% VDA-1102

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Keratosis, ActinicPrecancerous ConditionsCarcinoma, Squamous Cell

Interventions

Excipients

Condition Hierarchy (Ancestors)

NeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Pharmaceutical VehiclesPharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Results Point of Contact

Title
Max Herzberg
Organization
Vidac Pharma
maxherzberg@gmail.com
0544257381

Study Officials

  • Chaim M Brickman, MD

    Vidac Pharma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 26, 2016

Study Start

July 15, 2016

Primary Completion

May 26, 2017

Study Completion

May 26, 2017

Last Updated

January 12, 2023

Results First Posted

January 12, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.

Locations

US(1)