Actinic KeratosisPhase 2Phase2bNCT03538951
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
A Phase 2 study testing 10% VDA-1102 and 20% VDA-1102 in people with Actinic Keratosis, run by Vidac Pharma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- 10% VDA-1102 and 20% VDA-1102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2018to 10 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
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.
Read the detailed description
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").
- Conditions
- Actinic Keratosis
- Being tested
- 10% VDA-1102, 20% VDA-1102
- Keywords
- actinic keratosis, efficacy, safety, VDA-1102
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% VDA-1102Drug
Also called 10% VDA-1102 topical ointment
200 mg twice-daily for 12 weeks
20% VDA-1102Drug
Also called 20% VDA-1102 topical ointment
200 mg once-daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 10% VDA-1102 Receives: Drug: 10% VDA-1102 |
| Cohort 2 | Experimental | 20% VDA-1102 Receives: Drug: 20% VDA-1102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 16
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start23 May 2018
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3-part, open-label, multi-center study
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidac Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc., PharPoint Research, Inc., Medistat Ltd., Israel
- Responsible party
- Sponsor
- Investigators
- Mark G Lebwohl, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538951
- Sponsor's protocol ID
- VDA-CP-05
- Acronym
- Phase2b
- Status last verified
- May 2021
- First submitted
- 29 Apr 2018
- Last updated
- 23 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT03538951
- Acronym / sponsor ID
- Phase2b / VDA-CP-05
- Conditions
- Actinic Keratosis
- Keywords
- actinic keratosis, efficacy, safety, VDA-1102
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Vidac PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc., PharPoint Research, Inc., Medistat Ltd., Israel
- Study start
- 23 May 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 23 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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").
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3-part, open-label, multi-center study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 10% VDA-110210% VDA-1102 |
| Cohort 2 | Experimental | Drug: 20% VDA-110220% VDA-1102 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% VDA-1102Also: 10% VDA-1102 topical ointment200 mg twice-daily for 12 weeks | Drug | Cohort 1 |
| 20% VDA-1102Also: 20% VDA-1102 topical ointment200 mg once-daily for 12 weeks | Drug | Cohort 2 |
Primary outcome
Complete Clearance Rate
Time frame: Week 16
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
Complete Facial Clearance Rate
Time frame: Week 16
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
4 secondary outcomes
Partial Clearance
Time frame: 16 weeks
Partial Facial Clearance
Time frame: 16 weeks
Lesion Number Reduction
Time frame: 16 weeks
Lesion Number Reduction on Face
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark G Lebwohl, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10% VDA-1102 and 20% VDA-1102 in people with Actinic Keratosis, run by Vidac Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Clearance Rate (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.