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The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT01 plus Comp01 | Placebo Comparator | ACT01 Cream in combination with Comp01 Cream, once daily, 29 days |
|
| ACT01 plus Comp02 | Active Comparator | ACT01 Cream in combination with Comp02 Cream, once daily, 29 days |
|
| ACT01 plus Comp03 | Active Comparator | ACT01 Cream in combination with Comp03 Cream, once daily, 29 days |
|
| ACT01 plus Comp04 | Other | ACT01 Cream in combination with Comp04 Cream, once daily, 29 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT01 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success at End of Study Visit | Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions | up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Irritation Score | Percentage of participants with moderate or severe overall irritation at end of treatment. | up to Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States | ||
| Dermatology Specialists Research, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACT01 Plus Comp01 | ACT01 Cream in combination with Comp01 Cream, once daily, 29 days ACT01 Comp01 |
| FG001 | ACT01 Plus Comp02 | ACT01 Cream in combination with Comp02 Cream, once daily, 29 days ACT01 Comp02 |
| FG002 | ACT01 Plus Comp03 | ACT01 Cream in combination with Comp03 Cream, once daily, 29 days ACT01 Comp03 |
| FG003 | ACT01 Plus Comp04 | ACT01 Cream in combination with Comp04 Cream, once daily, 29 days ACT01 Comp04 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACT01 Plus Comp01 | ACT01 Cream in combination with Comp01 Cream, once daily, 29 days ACT01 Comp01 |
| BG001 | ACT01 Plus Comp02 | ACT01 Cream in combination with Comp02 Cream, once daily, 29 days ACT01 Comp02 |
| 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 | Treatment Success at End of Study Visit | Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions | Per protocol | Posted | Number | 95% Confidence Interval | percentage of participants | up to Day 57 |
|
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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 | ACT01 Plus Comp01 | ACT01 Cream in combination with Comp01 Cream, once daily, 29 days ACT01 Comp01 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Stenosis | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Irritation | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Promius Pharma, LLC | 609-282-1476 | kgulbronson@promiuspharma.com |
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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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| Comp01 |
| Drug |
|
| Comp02 | Drug |
|
| Comp03 | Drug |
|
| Comp04 | Drug |
|
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Dermatology Consulting Services; Zoe Diana Draelos, MD | High Point | North Carolina | 27262 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| BG002 | ACT01 Plus Comp03 | ACT01 Cream in combination with Comp03 Cream, once daily, 29 days ACT01 Comp03 |
| BG003 | ACT01 Plus Comp04 | ACT01 Cream in combination with Comp04 Cream, once daily, 29 days ACT01 Comp04 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days ACT01 Comp03 |
| OG003 | ACT01 Plus Comp04 | ACT01 Cream in combination with Comp04 Cream, once daily, 29 days ACT01 Comp04 |
|
|
|
| Secondary | Irritation Score | Percentage of participants with moderate or severe overall irritation at end of treatment. | Overall irritation | Posted | Number | percentage of participants | up to Day 57 |
|
|
|
| 0 |
| 26 |
| 22 |
| 26 |
| EG001 | ACT01 Plus Comp02 | ACT01 Cream in combination with Comp02 Cream, once daily, 29 days ACT01 Comp02 | 0 | 24 | 24 | 24 |
| EG002 | ACT01 Plus Comp03 | ACT01 Cream in combination with Comp03 Cream, once daily, 29 days ACT01 Comp03 | 0 | 25 | 20 | 25 |
| EG003 | ACT01 Plus Comp04 | ACT01 Cream in combination with Comp04 Cream, once daily, 29 days ACT01 Comp04 | 1 | 25 | 24 | 25 |
| Headache | Nervous system disorders |
|
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| D017437 |
| Skin and Connective Tissue Diseases |