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This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled, multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult subjects.
Approximately 84 subjects who meet the study's enrollment criteria at the completion of the Screening Period will be randomized to receive 5% or 10% VDA-1102, or matched-placebo. During the Treatment Period, study drug will be applied once-daily for 28 days to a 25 square centimeter area of skin containing 4-8 actinic keratosis lesions on the face or scalp. Subjects will be followed for an additional 28 days (Observation Period) wherein no study drug will be applied.
The purpose of the study is to determine whether once-daily application of VDA-1102 ointment for 28 days is effective and well-tolerated in the treatment of actinic keratosis of the face and scalp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Excipeint alone |
|
| 5% VDA-1102 | Experimental | Active study medication |
|
| 10% VDA-1102 | Experimental | Active study medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 200 mg applied once-daily for 28 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56 | To compare the reduction on Day 56 in the number of the actinic keratosis (AK) lesions in the Treatment Field of subjects receiving once-daily topical 5% or 10% VDA-1102 ointment for 28 days to the reduction in the number of AK lesions in subjects receiving placebo. | Baseline and day 56 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complete Clearance of Actinic Keratosis Lesions in the Treatment Field | The percentage of subjects achieving complete clearance of AK lesions within the Treatment Field on Day 56. | Baseline and Day 56 |
| Change From Baseline in the Number of AK Lesions Within the Treatment Field of Each Subject on Day 84. |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chaim M Brickman, MD | Vidac Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
IPD will not be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Excipeint alone Placebo: 200 mg applied once-daily for 28 days |
| FG001 | 5% VDA-1102 | Active study medication 5% VDA-1102: 200 mg applied once-daily for 28 days |
| FG002 | 10% VDA-1102 | Active study medication 10% VDA-1102: 200 mg applied once-daily for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Excipeint alone Placebo: 200 mg applied once-daily for 28 days |
| BG001 | 5% VDA-1102 | Active study medication 5% VDA-1102: 200 mg applied once-daily for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change From Baseline in the Number of Actinic Keratosis Lesions in the Treatment Field on Day 56 | To compare the reduction on Day 56 in the number of the actinic keratosis (AK) lesions in the Treatment Field of subjects receiving once-daily topical 5% or 10% VDA-1102 ointment for 28 days to the reduction in the number of AK lesions in subjects receiving placebo. | ITT | Posted | Mean | Standard Deviation | lesions | Baseline and day 56 |
|
Screening to Day 84
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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 | Placebo | Excipeint alone Placebo: 200 mg applied once-daily for 28 days | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| benign sero-mucinous cystadenoma of abdomen | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 19.1 | 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 | Yes | No | No | Study Protocol | Oct 31, 2016 | Sep 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2017 | Sep 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D011230 | Precancerous Conditions |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005079 | Excipients |
| ID | Term |
|---|---|
| D014677 | Pharmaceutical Vehicles |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
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| 5% VDA-1102 | Drug | 200 mg applied once-daily for 28 days |
|
|
| 10% VDA-1102 | Drug | 200 mg applied once-daily for 28 days |
|
|
To compare the reduction on Day 84 in the number of the actinic keratosis lesions |
| Baseline and day 84 |
| AK Grade 2 Lesions Number: Change From Baseline (Day 1 Pre-dose) in Sub-group of Subjects With at Least One Grade 2 Lesion at Baseline (From ITT Population) | Change from Baseline (Day 1 Pre-dose) in Sub-group of Subjects with at least one Grade 2 Lesion at Baseline (from ITT Population)in the number of grade ≥ 2 lesions. Grade 2 defined as: moderate (moderately thick AK that are easily seen and felt) | Baseline and day 56 |
| Change From Baseline in the Adjusted Number of Lesions Weighted by Grade ([Number of Grade 1 Lesions] + [2× Number of Grade 2 Lesions] + [3× Number of Grade 3 Lesions]) | Change From Baseline in the Adjusted Number of Lesions Weighted by Grade ([Number of Grade 1 Lesions] + [2× Number of Grade 2 Lesions] + [3× Number of Grade 3 Lesions]) Grade 1 - mild (slightly palpable AK that are felt better than seen) Grade 2 - moderate (moderately thick AK that are easily seen and felt) Grade 3 - severe (very thick and/or obvious AK). | Baseline and day 56 |
| BG002 | 10% VDA-1102 | Active study medication 10% VDA-1102: 200 mg applied once-daily for 28 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick skin types | Count of Participants | Participants |
|
| Treatment field location | Count of Participants | Participants |
|
| OG002 | 10% VDA-1102 | Active study medication 10% VDA-1102: 200 mg applied once-daily for 28 days |
|
|
|
| Other Pre-specified | Percentage of Patients With Complete Clearance of Actinic Keratosis Lesions in the Treatment Field | The percentage of subjects achieving complete clearance of AK lesions within the Treatment Field on Day 56. | ITT population | Posted | Count of Participants | Participants | Baseline and Day 56 |
|
|
|
|
| Other Pre-specified | Change From Baseline in the Number of AK Lesions Within the Treatment Field of Each Subject on Day 84. | To compare the reduction on Day 84 in the number of the actinic keratosis lesions | ITT population | Posted | Mean | Standard Deviation | lesions | Baseline and day 84 |
|
|
|
|
| Other Pre-specified | AK Grade 2 Lesions Number: Change From Baseline (Day 1 Pre-dose) in Sub-group of Subjects With at Least One Grade 2 Lesion at Baseline (From ITT Population) | Change from Baseline (Day 1 Pre-dose) in Sub-group of Subjects with at least one Grade 2 Lesion at Baseline (from ITT Population)in the number of grade ≥ 2 lesions. Grade 2 defined as: moderate (moderately thick AK that are easily seen and felt) | Posted | Mean | Standard Deviation | lesions | Baseline and day 56 |
|
|
|
|
| Other Pre-specified | Change From Baseline in the Adjusted Number of Lesions Weighted by Grade ([Number of Grade 1 Lesions] + [2× Number of Grade 2 Lesions] + [3× Number of Grade 3 Lesions]) | Change From Baseline in the Adjusted Number of Lesions Weighted by Grade ([Number of Grade 1 Lesions] + [2× Number of Grade 2 Lesions] + [3× Number of Grade 3 Lesions]) Grade 1 - mild (slightly palpable AK that are felt better than seen) Grade 2 - moderate (moderately thick AK that are easily seen and felt) Grade 3 - severe (very thick and/or obvious AK). | ITT population | Posted | Mean | Standard Deviation | lesions | Baseline and day 56 |
|
|
|
|
| 29 |
| 0 |
| 29 |
| 3 |
| 29 |
| EG001 | 5% VDA-1102 | Active study medication 5% VDA-1102: 200 mg applied once-daily for 28 days | 0 | 32 | 1 | 32 | 1 | 32 |
| EG002 | 10% VDA-1102 | Active study medication 10% VDA-1102: 200 mg applied once-daily for 28 days | 0 | 32 | 1 | 32 | 4 | 32 |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
|
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| D002277 |
| Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D020164 | Chemical Actions and Uses |
| Male |
|
| Title | Measurements |
|---|---|
|
| II : White skin, usually burns easily, tans minimall |
|
| III : Light brown skin, burns moderately, tans uniformly |
|
| IV : Moderate brown skin, burns minimally, always tans well. |
|
| Scalp |
|
| Other |
| Other |
| Other |
| Other |