Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10% VDA-1102 | Drug | — | UNRESOLVED |
| 20% VDA-1102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 10% VDA-1102
- interventionNames
- Drug: 10% VDA-1102
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 20% VDA-1102
- interventionNames
- Drug: 20% VDA-1102
Primary outcomes (2)
- measure
- Complete Clearance Rate
- timeFrame
- Week 16
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available