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Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis (Phase2b)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03538951
Recruitment Status : Unknown
Verified May 2018 by Vidac Pharma.
Recruitment status was:  Recruiting
First Posted : May 29, 2018
Last Update Posted : May 30, 2018
Sponsor:
Collaborators:
Therapeutics, Inc.
PharPoint Research, Inc.
Medistat Ltd., Israel
Information provided by (Responsible Party):
Vidac Pharma

Tracking Information
First Submitted Date  ICMJE April 29, 2018
First Posted Date  ICMJE May 29, 2018
Last Update Posted Date May 30, 2018
Actual Study Start Date  ICMJE May 23, 2018
Estimated Primary Completion Date January 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Complete clearance rate [ Time Frame: Week 16 ]
    Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm
  • Complete facial clearance rate [ Time Frame: Week 16 ]
    Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Adverse events [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of adverse events in each treatment arm
  • Vital signs - systolic bood pressure [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal systolic blood pressures of subjects in each treatment arm
  • Vital signs - diastolic bood pressure [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal diastolic blood pressures of subjects in each treatment arm
  • Vital signs - heart rate [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal heart rates of subjects in each treatment arm
  • Vital signs - respiratory rates [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal respiratory rates of subjects in each treatment arm
  • Vital signs - oral temperature [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal systolic blood pressures of subjects in each treatment arm
  • Physical examination findings [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal physical examinations findings of subjects in each treatment arm
  • Clinical chemistry results [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal clinical chemistry results of subjects in each treatment arm
  • Hematology results [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal hematology results of subjects in each treatment arm
  • Coagulation results [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal coagulation results of subjects in each treatment arm
  • Urinalysis results [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal urinalysis results of subjects in each treatment arm
  • Electrocardiograms [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal electrocardiograms of subjects in each treatment arm
  • Local skin reactions [ Time Frame: 16 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal local skin reactions of subjects in each treatment arm
  • Compliance - doses applied [ Time Frame: 12 weeks ]
    To evaluate the safety of VDA-1102 by the mean number of doses applied by subjects of subjects in each treatment arm
  • Compliance - tube weight reduction [ Time Frame: 12 weeks ]
    To evaluate the safety of VDA-1102 by the mean decrement in tube weight of subjects of subjects in each treatment arm
  • Partial clearance [ Time Frame: 16 weeks ]
    Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of AK lesions in the selected area of subjects of subjects in each treatment arm
  • Partial facial clearance [ Time Frame: 16 weeks ]
    Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of facial AK lesions in the selected area of subjects in each treatment arm
  • Lesion number reduction [ Time Frame: 16 weeks ]
    Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm
  • Lesion number reduction on face [ Time Frame: 16 weeks ]
    Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Official Title  ICMJE Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Brief Summary This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
3-part, open-label, multi-center study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Actinic Keratosis
Intervention  ICMJE
  • Drug: 10% VDA-1102
    200 mg twice-daily for 12 weeks
    Other Name: 10% VDA-1102 topical ointment
  • Drug: 20% VDA-1102
    200 mg once-daily for 12 weeks
    Other Name: 20% VDA-1102 topical ointment
Study Arms  ICMJE
  • Experimental: Cohort 1
    10% VDA-1102
    Intervention: Drug: 10% VDA-1102
  • Experimental: Cohort 2
    20% VDA-1102
    Intervention: Drug: 20% VDA-1102
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2019
Estimated Primary Completion Date January 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp

Exclusion Criteria:

  • Subject has no clinically significant findings at Baseline
  • Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline
  • Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem
  • Subject has at any time been given a diagnosis or treatment associated with immunosuppression
  • Subject has received VDA-1102 in the past
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03538951
Other Study ID Numbers  ICMJE VDA-CP-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vidac Pharma
Study Sponsor  ICMJE Vidac Pharma
Collaborators  ICMJE
  • Therapeutics, Inc.
  • PharPoint Research, Inc.
  • Medistat Ltd., Israel
Investigators  ICMJE
Principal Investigator: Mark G Lebwohl, MD Icahn School of Medicine at Mount Sinai
PRS Account Vidac Pharma
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP