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

Actinic Keratosis Clinical Trial

— Phase2b  

Official title:

Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538951
• Other study ID #: VDA-CP-05
• Status: Completed
• Phase: Phase 2
• Start date: May 23, 2018
• Est. completion date: December 10, 2018

Study information

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

Clinical Trial 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.

Description:

This Phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of VDA-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. The first 40 eligible subjects will be enrolled into Cohort 1 (Part A). Cohort 1 subjects will be assigned to receive approximately 200 mg of 10% VDA-1102 twice-daily (BID). Once approximately 40 subjects have been enrolled in Cohort 1, Cohort 1 will be closed to enrollment and Cohort 2 (Part B) will be opened for enrollment. Cohort 2 subjects will be assigned to receive approximately 200 mg of 20% VDA-1102 once-daily (QD). Once approximately 40 subjects have been enrolled in Cohort 2, an additional 70 subjects will be randomly assigned to Cohort 1 or Cohort 2 (Part C) in a 1:1 ratio.

To qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (AK) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the "Treatment Field").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• 10% VDA-1102
200 mg twice-daily for 12 weeks
• 20% VDA-1102
200 mg once-daily for 12 weeks

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Vidac Pharma	Medistat Ltd., Israel, PharPoint Research, Inc., Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Clearance Rate	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	Week 16
Primary	Complete Facial Clearance Rate	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	Week 16
Secondary	Partial Clearance	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	16 weeks
Secondary	Partial Facial Clearance	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	16 weeks
Secondary	Lesion Number Reduction	Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm	16 weeks
Secondary	Lesion Number Reduction on Face	Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm	16 weeks