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

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ClinicalTrials.gov Identifier: NCT02844777
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Placebo Drug: 5% VDA-1102 Drug: 10% VDA-1102 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
200 mg applied once-daily for 28 days
Other Names:
  • Excipients alone
  • Matched-placebo

Experimental: 5% VDA-1102 Drug: 5% VDA-1102
200 mg applied once-daily for 28 days
Other Name: 5% VDA-1102 topical dermal ointment

Experimental: 10% VDA-1102 Drug: 10% VDA-1102
200 mg applied once-daily for 28 days
Other Name: 10% VDA-1102 topical dermal ointment




Primary Outcome Measures :
  1. Number of actinic keratosis lesions in the Treatment Field [ Time Frame: 56 days ]

Secondary Outcome Measures :
  1. Number and percent of subjects with adverse events (AEs) and treatment emergent AEs. [ Time Frame: Baseline and Days 7, 14, 28, 35, and 56. ]
    The incidence of AEs, as well as the intensity and relationship to study drug will be summarized by treatment group.

  2. Physical examinations [ Time Frame: Baseline and Days 7, 14, 28, 35 and 56. ]
    Abnormal findings will be listed per treatment group.

  3. Vital signs - systolic and diastolic blood pressures [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables (mm Hg) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  4. Vital signs - heart rate [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables (beats per minute) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  5. Vital signs - temperature [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables (degrees Centigrade) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  6. Vital signs - respiratory rate [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables (breaths per minute) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  7. Local Skin Reaction Scores [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  8. Clinical laboratory test results [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables (Standardized International Units) will be described as the mean, median, standard deviation, upper and lower 25% quartiles, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  9. 12-lead electrocardiographic data - RR intervals [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables (milliseconds) will be described as the mean, median, standard deviation, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  10. 12-lead electrocardiographic data - Heart Rates [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables (beats per minute) will be described as the mean, median, standard deviation, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  11. 12-lead electrocardiographic data - PR, QRS, QT, QTcF, and QTcB intervals [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These continuous variables (milliseconds) will be described as the mean, median, standard deviation, and minimum and maximum values of n observations. Findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  12. 12-lead electrocardiographic data - Abnormal tracing interpretations [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    These categorical data (i.e., abnormal / normal) will be described with contingency tables including frequency and percent. These findings will be summarized and compared between treatments and within treatment groups compared to findings from baseline evaluations.

  13. Withdrawals [ Time Frame: Baseline through Day 56. ]
    The number of subjects withdrawn per treatment group due to adverse events will be summarized.

  14. Plasma Concentration (C) of VDA-1102 [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    Plasma Concentration (C) of VDA-1102 will be measures at a single time point on Days 7, 14, 28 and 35 approximately 12 hours post dose. In addition, on Day 28 samples will be drawn at approximately 15, 18, and 21 hours post dose as well.

  15. Plasma Concentration (C) of main VDA-1102 metabolite [ Time Frame: Baseline and Days 7, 14, 28, and 35. ]
    Plasma Concentration (C) of the main VDA-1102 metabolite will be measures at a single time point on Days 7, 14, 28 and 35 approximately 12 hours post dose. In addition, on Day 28 samples will be drawn at approximately 15, 18, and 21 hours post dose as well.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844777


Locations
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United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
Sponsors and Collaborators
Vidac Pharma
Investigators
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Study Director: Chaim M Brickman, MD Vidac Pharma

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Responsible Party: Vidac Pharma
ClinicalTrials.gov Identifier: NCT02844777     History of Changes
Other Study ID Numbers: VDA-CP-03
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A decision has not been made whether to share individual participant data.

Keywords provided by Vidac Pharma:
topical ointment
skin
hexokinase
precancerous conditions
carcinoma, squamous cell

Additional relevant MeSH terms:
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Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms