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Sponsored by: |
Cytotech Labs, LLC |
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Information provided by: | Cytotech Labs, LLC |
ClinicalTrials.gov Identifier: | NCT00604890 |
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.
Condition | Intervention | Phase |
---|---|---|
Superficial Basal Cell Carcinoma |
Drug: API 31510 Topical Cream |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 160 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Active cream, 3% AM & PM
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Drug: API 31510 Topical Cream
Topical treatment to lesion twice daily of randomized treatments that include 1.5% active cream, 3% active cream or placebo cream
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2: Placebo Comparator
Placebo cream AM ; 3% active cream PM
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Drug: API 31510 Topical Cream
Topical treatment to lesion twice daily of randomized treatments that include 1.5% active cream, 3% active cream or placebo cream
|
3: Placebo Comparator
Placebo cream AM; 1.5% active cream PM
|
Drug: API 31510 Topical Cream
Topical treatment to lesion twice daily of randomized treatments that include 1.5% active cream, 3% active cream or placebo cream
|
4: Placebo Comparator
Placebo AM and PM
|
Drug: API 31510 Topical Cream
Topical treatment to lesion twice daily of randomized treatments that include 1.5% active cream, 3% active cream or placebo cream
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Burke Pharmaceuticals | |
Hot Springs, Arkansas, United States, 71913 | |
United States, California | |
Skin Surgery Medical Group, Inc. | |
San Diego, California, United States, 92108 | |
United States, Colorado | |
Colorado Medical Research Center | |
Denver, Colorado, United States, 80210 | |
United States, Florida | |
Dermatology Associates and Research | |
Coral Gables, Florida, United States, 33134 | |
United States, Georgia | |
Gwinnett Clinical Research | |
Snellville, Georgia, United States, 30078 | |
United States, Illinois | |
Christie Clinic | |
Champaign, Illinois, United States, 61820 | |
Scott D. Glazer, M.D., S.C. | |
Buffalo Grove, Illinois, United States, 60089 | |
United States, New York | |
Long Island Skin Cancer and Dermatologic Surgery, PC | |
Smithtown, New York, United States, 11787 | |
United States, Oregon | |
Oregon Dermatology and Research Center | |
Portland, Oregon, United States, 97210 | |
United States, Texas | |
Dermatology Clinical Research Center of San Antonio | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Education & Research Foundation | |
Lynchburg, Virginia, United States, 24501 |
Principal Investigator: | David Wilson, MD | Education and Research Foundation |
Responsible Party: | Cytotech Labs, LLC ( Nick Martinez/Regulatory Specialist ) |
Study ID Numbers: | CTL0108 |
Study First Received: | January 17, 2008 |
Last Updated: | May 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00604890 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Double-Blind Placebo Topical |
Treatment Dose-Ranging sBCC |
Neoplasms, Basal Cell Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell |
Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Carcinoma |