Phase 2
N=93
Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT02844777 ↗Enrolled (actual)
93
Serious AEs
2.2%
Results posted
Jan 2023
Primary outcome: Primary: Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56 — -1.54; -1.34; -1.94 lesions — p=0.9518
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); 5% VDA-1102 (Drug); 10% VDA-1102 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vidac Pharma
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56 |
-1.54; -1.34; -1.94 | 0.9518 |
Summary
This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled, multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult subjects.
Eligibility Criteria
Main Inclusion Criteria:
- Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a single 25 square centimeter area of skin on their scalp or face
Main Exclusion Criteria:
- Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the study, or (d) fertile and they or their fertile partner is unable or unwilling to use the required contraceptive methods
- Subject is immunosuppressed
- Subject has used any of the following topical treatments in the Treatment Field: (1) topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or other topical treatments for AK or that might impact AK within 12 weeks of Screening.
- Subject has used systemic retinoid therapy within 6 months of Screening Visit.
Data sourced from ClinicalTrials.gov (NCT02844777). 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.