Phase 2
Completed N=83
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Source: ClinicalTrials.gov NCT03538951 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Complete Clearance Rate — 7; 9 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clearance Rate |
7; 9 | — |
| PRIMARY Complete Facial Clearance Rate |
5; 8 | — |
| SECONDARY Partial Clearance |
12; 14 | — |
| SECONDARY Partial Facial Clearance |
8; 13 | — |
| SECONDARY Lesion Number Reduction |
-46.00; -52.66 | — |
| SECONDARY Lesion Number Reduction on Face |
-48.51; -62.42 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03538951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.