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Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Phase 2 trial testing 10% VDA-1102 in Actinic Keratosis in 83 participants. Completed in 10 December 2018.
| Lead sponsor | Vidac Pharma |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 83 |
| Start date | 23 May 2018 |
| Primary completion | 10 December 2018 |
| Estimated completion | 10 December 2018 |
| Sites | 1 location across United States |
Vidac Pharma — full company profile →
18 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 7 | |
| Cohort 2 | 9 |
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
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 5 | |
| Cohort 2 | 8 |
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
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 12 | |
| Cohort 2 | 14 |
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
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 8 | |
| Cohort 2 | 13 |
Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | -46.00 | ± 36.47 |
| Cohort 2 | -52.66 | ± 37.31 |
Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | -48.51 | ± 37.35 |
| Cohort 2 | -62.42 | ± 34.02 |
Erythema (score=0 or score \>0) week 8 100% clearance week 16 (Face and Scalp)
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 2 | |
| Cohort 2 | 4 | |
| Cohort 1 | 21 | |
| Cohort 2 | 24 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 5 | |
| Cohort 2 | 6 | |
| Cohort 1 | 12 | |
| Cohort 2 | 5 |
Erythema (score=0 or score \>0) week 8 75% clearance week 16 (Face and Scalp)
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0 | |
| Cohort 2 | 5 | |
| Cohort 1 | 0 | |
| Cohort 2 | 23 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0 | |
| Cohort 2 | 6 | |
| Cohort 1 | 0 | |
| Cohort 2 | 3 |
Time frame: From screening until week 16. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1 | Cohort 2 |
|---|---|---|---|
| Skin reaction | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT03538951 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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