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| Name | Class |
|---|---|
| Therapeutics, Inc. | INDUSTRY |
| PharPoint Research, Inc. | INDUSTRY |
| Medistat Ltd., Israel | INDUSTRY |
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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").
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 10% VDA-1102 |
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| Cohort 2 | Experimental | 20% VDA-1102 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% VDA-1102 | Drug | 200 mg twice-daily for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 16 weeks |
| Partial Facial Clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark G Lebwohl, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks |
| FG001 | Cohort 2 | 20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | 10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks |
| BG001 | Cohort 2 | 20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | mITT | Posted | Count of Participants | Participants | Week 16 |
|
From screening until week 16
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | 10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Max Herzberg | Vidac Pharma | 0544257381 | maxherzberg@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2018 | Jul 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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3-part, open-label, multi-center study
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| 20% VDA-1102 | Drug | 200 mg once-daily for 12 weeks |
|
|
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
| 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 | 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 | 16 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Primary | 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 | mITT | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| Secondary | 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 | mITT | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | 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 | mITT | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Lesion Number Reduction | Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm | mITT | Posted | Mean | Standard Deviation | percentage of change from baseline | 16 weeks |
|
|
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| Secondary | 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 | mITT | Posted | Mean | Standard Deviation | Percentage of change from baseline | 16 weeks |
|
|
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| Post-Hoc | Complete Clearance in Patients With Local Skin Reaction- Erythema | Erythema (score=0 or score >0) week 8 100% clearance week 16 (Face and Scalp) | Data analyzed by patients with erythema score =0 or > 0 | Posted | Count of Participants | Participants | Week 16 |
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| Post-Hoc | Lesion Reduction in Patients With Local Skin Reaction- Erythema | Erythema (score=0 or score >0) week 8 75% clearance week 16 (Face and Scalp) | Data no analyzed for cohort 1 (10% VDA-1102) | Posted | Count of Participants | Participants | Week 16 |
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|
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| 41 |
| 0 |
| 41 |
| 10 |
| 41 |
| EG001 | Cohort 2 | 20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks | 0 | 42 | 0 | 42 | 10 | 42 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| No complete clearance |
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| Erythema score > 0 |
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| Less than 75% lesion reduction |
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| Erythema score >0 |
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