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

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ClinicalTrials.gov Identifier: NCT03538951
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : May 30, 2018
Sponsor:
Collaborators:
Therapeutics, Inc.
PharPoint Research, Inc.
Medistat Ltd., Israel
Information provided by (Responsible Party):
Vidac Pharma

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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: 10% VDA-1102 Drug: 20% VDA-1102 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 3-part, open-label, multi-center study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
10% VDA-1102
Drug: 10% VDA-1102
200 mg twice-daily for 12 weeks
Other Name: 10% VDA-1102 topical ointment

Experimental: Cohort 2
20% VDA-1102
Drug: 20% VDA-1102
200 mg once-daily for 12 weeks
Other Name: 20% VDA-1102 topical ointment




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of adverse events in each treatment arm

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Electrocardiograms [ Time Frame: 21 weeks ]
    To evaluate the safety of VDA-1102 by the proportion of abnormal electrocardiograms of subjects in each treatment arm

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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



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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

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

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): NCT03538951


Contacts
Contact: Chaim M Brickman, MD +972546855134 cbrick77@yahoo.com
Contact: Galit Zelinger +972545667741 gzelinger@vidacpharma.com

Locations
United States, California
Therapeutics Clinical Research Recruiting
San Diego, California, United States, 92123
Contact: Ericka Garcia    858-571-6800    egarcia@therapeuticsresearch.com   
Principal Investigator: Neal Bhatia, MD         
Sponsors and Collaborators
Vidac Pharma
Therapeutics, Inc.
PharPoint Research, Inc.
Medistat Ltd., Israel
Investigators
Principal Investigator: Mark G Lebwohl, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Vidac Pharma
ClinicalTrials.gov Identifier: NCT03538951     History of Changes
Other Study ID Numbers: VDA-CP-05
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vidac Pharma:
actinic keratosis
efficacy
safety
VDA-1102

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