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The purpose of this study is to determine the safety and tolerability of pharmaceutical compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by API 31510 topical cream. The study population will include one hundred and sixty (160) otherwise healthy male or female adults with one or more histologically confirmed superficial basal cell carcinoma lesions. One target lesion with an area of less than one inch will be designated for study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Active cream, 3% AM & PM |
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| 2 | Placebo Comparator | Placebo cream AM ; 3% active cream PM |
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| 3 | Placebo Comparator | Placebo cream AM; 1.5% active cream PM |
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| 4 | Placebo Comparator | Placebo AM and PM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| API 31510 3% Topical Cream | Drug | Topical treatment 3% active cream applied to the lesion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response | To determine the number of participants with a complete response, defined as a negative histological examination of the sBCC lesion at Week 10 (4 weeks post-treatment). | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Partial Response | To determine the number of participants with a partial response, defined as a clinically significant decrease (ie, at least 50%) in the area of the sBCC lesion, computed as the product of the two principal diameters at Week 10 (4 weeks post-treatment) | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wilson, MD | Education and Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceuticals | Hot Springs | Arkansas | 71913 | United States | ||
| Skin Surgery Medical Group, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3% Active Cream BID(Twice Daily) | Topical Treatment 3.0% active cream applied to the lesion twice daily (BID) |
| FG001 | 3% Active Cream QD(Once Daily) | Topical treatment 3.0% active cream applied to the lesion once daily (PM) plus placebo cream applied to the lesion once daily (AM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| API 31510 1.5% Topical Cream | Drug | Topical treatment 1.5% active cream applied to the lesion |
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| Placebo | Other | Topical treatment placebo applied to the lesion |
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| San Diego |
| California |
| 92108 |
| United States |
| Colorado Medical Research Center | Denver | Colorado | 80210 | United States |
| Dermatology Associates and Research | Coral Gables | Florida | 33134 | United States |
| Gwinnett Clinical Research | Snellville | Georgia | 30078 | United States |
| Scott D. Glazer, M.D., S.C. | Buffalo Grove | Illinois | 60089 | United States |
| Christie Clinic | Champaign | Illinois | 61820 | United States |
| Long Island Skin Cancer and Dermatologic Surgery, PC | Smithtown | New York | 11787 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Education & Research Foundation | Lynchburg | Virginia | 24501 | United States |
| FG002 | 1.5% Active Cream QD(Once Daily) | Topical treatment 1.5% active cream applied to the lesion once daily (PM) plus placebo cream applied to the lesion once daily (AM) |
| FG003 | Placebo BID(Twice Daily) | Placebo cream applied to the lesion twice daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 3% BID | 3.0% active twice daily (BID) |
| BG001 | 3% QD | 3.0% active cream once daily (QD) plus placebo cream QD |
| BG002 | 1.5% QD | 1.5% active cream once daily (QD) plus placebo cream QD |
| BG003 | Placebo | Placebo cream twice daily (BID) |
| BG004 | Total | Total of all reporting groups |
| 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 | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Participants With Complete Response | To determine the number of participants with a complete response, defined as a negative histological examination of the sBCC lesion at Week 10 (4 weeks post-treatment). | Posted | Count of Participants | Participants | 10 weeks |
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| Secondary | Number of Participants With Partial Response | To determine the number of participants with a partial response, defined as a clinically significant decrease (ie, at least 50%) in the area of the sBCC lesion, computed as the product of the two principal diameters at Week 10 (4 weeks post-treatment) | Posted | Count of Participants | Participants | 10 weeks |
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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 | 3% Active Cream BID | 3.0% active cream twice daily (BID) | 3 | 47 | 14 | 47 | ||
| EG001 | 3% QD | 3.0% active cream once daily QD plus placebo cream QD | 0 | 45 | 22 | 45 | ||
| EG002 | 1.5% QD | 1.5% active cream once daily (QD) plus placebo cream QD | 0 | 48 | 18 | 48 | ||
| EG003 | Placebo BID | Placebo cream twice daily (BID) | 0 | 46 | 26 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blockage ( L ) Anterior Artery/Percutaneous Coronary Intervention (Stent) # 6 = Primary Care | Cardiac disorders |
| |||
| Sepsis | Infections and infestations |
| |||
| Sudden Death | Cardiac disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Etythema | Skin and subcutaneous tissue disorders | The most frequently reported treatment-emergent AE was application site erythema, which was reported in 33 of 186 subjects (17.7 %) in the overall safety population |
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| Application Site Dryness | Skin and subcutaneous tissue disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Application Site Exfoliation | Skin and subcutaneous tissue disorders |
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| Nasopharyngitis | Infections and infestations |
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| Urinary tract infection | Infections and infestations |
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| Application site pruritus | Skin and subcutaneous tissue disorders |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders |
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| Application site bleeding | General disorders |
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| Upper respiratory tract infection | Infections and infestations |
| |||
| Dry Skin | Skin and subcutaneous tissue disorders |
| |||
| Bronchitis | Infections and infestations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathaniel DiTommaso | Berg LLC | 617-588-1002 | nate.ditommaso@berghealth.com |
| Male |
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