A Phase 2 interventional study of 10% VDA-1102 and 20% VDA-1102 in Actinic Keratosis, sponsored by Vidac Pharma. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-23.
Sponsored by Vidac Pharma · Phase 2, Interventional, and Treatment
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.
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").
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 83 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Vidac Pharma is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10% VDA-1102
Drug: 10% VDA-1102
20% VDA-1102
Drug: 20% VDA-1102
200 mg twice-daily for 12 weeks
Also known as: 10% VDA-1102 topical ointment
200 mg once-daily for 12 weeks
Also known as: 20% VDA-1102 topical ointment
Complete Clearance Rate
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
Time frame: Week 16
Complete Facial Clearance Rate
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
Time frame: Week 16
Partial Clearance
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
Time frame: 16 weeks
Partial Facial Clearance
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
Time frame: 16 weeks
Lesion Number Reduction
Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm
Time frame: 16 weeks
Lesion Number Reduction on Face
Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm
Time frame: 16 weeks
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 41 | 42 |
| Completed | 40 | 40 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 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
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Complete Clearance Rate | 7 | 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
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Complete Facial Clearance Rate | 5 | 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
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Partial Clearance | 12 | 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
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Partial Facial Clearance | 8 | 13 |
Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm
| percentage of change from baseline | Cohort 1 | Cohort 2 |
|---|---|---|
| Lesion Number Reduction | -46.00 ± 36.47 | -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
| Percentage of change from baseline | Cohort 1 | Cohort 2 |
|---|---|---|
| Lesion Number Reduction on Face | -48.51 ± 37.35 | -62.42 ± 34.02 |
Erythema (score=0 or score \>0) week 8 100% clearance week 16 (Face and Scalp)
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Erythema score = 0 — Complete clearance | 2 | 4 |
| Erythema score = 0 — No complete clearance | 21 | 24 |
| Erythema score > 0 — Complete clearance | 5 | 6 |
| Erythema score > 0 — No complete clearance | 12 | 5 |
Erythema (score=0 or score \>0) week 8 75% clearance week 16 (Face and Scalp)
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Erythema score=0 — 75% lesion reduction | 0 | 5 |
| Erythema score=0 — Less than 75% lesion reduction | 0 | 23 |
| Erythema score >0 — 75% lesion reduction | 0 | 6 |
| Erythema score >0 — Less than 75% lesion reduction | 0 | 3 |
Collected over From screening until week 16. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/41 (0%) | 0/41 (0%) | 10/41 (24.4%) |
| Cohort 2 | 0/42 (0%) | 0/42 (0%) | 10/42 (23.8%) |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| Skin reactionSkin and subcutaneous tissue disorders | 10/41 | 10/42 |
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 66.5 ± 7.5 | 66.4 ± 9.2 | 66.4 ± 8.3 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 6 | 9 | 15 |
| Male | 35 | 33 | 68 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 41 | 42 | 83 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 41 | 42 | 83 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vidac Pharma