Title
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Phase
Phase 2Lead Sponsor
Vidac PharmaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Actinic KeratosisIntervention/Treatment
10% VDA-1102 20% VDA-1102Study Participants
83This 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.
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").
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
| Event Type | Organ System | Event Term | Cohort 1 | Cohort 2 |
|---|
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
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
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
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
Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm
Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm
Erythema (score=0 or score >0) week 8 100% clearance week 16 (Face and Scalp)
Erythema (score=0 or score >0) week 8 75% clearance week 16 (Face and Scalp)
