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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: | February 2009 |
Estimated Primary Completion Date: | February 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:
Contact: Karyn Monte | (201) 587-0500 ext 3368 | |
Contact: Susan Shlanger | (201) 587-0500 |
United States, Arkansas | |
Burke Pharmaceuticals | Recruiting |
Hot Springs, Arkansas, United States, 71913 | |
Contact: Tim Dugan 501-620-4449 | |
Principal Investigator: Dow Stough | |
Sub-Investigator: Marcia Starns, PA-C | |
United States, California | |
Skin Surgery Medical Group, Inc. | Recruiting |
San Diego, California, United States, 92108 | |
Contact: Alisa Schweikl, RN 858-292-8641 | |
Principal Investigator: Kenneth Gross, MD | |
Sub-Investigator: Leslie Mark, MD | |
Sub-Investigator: Dale E. Martin, MD | |
Sub-Investigator: Barbara E. Martin, MD | |
United States, Colorado | |
Colorado Medical Research Center | Recruiting |
Denver, Colorado, United States, 80210 | |
Contact: James Swinehart, MD 303-744-7000 | |
Contact: Carolyn Schmidt (303)744-7000 | |
Principal Investigator: James Swinehart, MD | |
United States, Florida | |
Dermatology Associates and Research | Recruiting |
Coral Gables, Florida, United States, 33134 | |
Contact: Ariadna Abiascal 305-567-1930 | |
Principal Investigator: David Rodriguez, MD | |
Sub-Investigator: Lizbeth Mendoza, MD | |
United States, Georgia | |
Gwinnett Clinical Research | Recruiting |
Snellville, Georgia, United States, 30078 | |
Contact: Linda Davis 770-972-2241 | |
Contact: Leslie McNeil 770-972-2241 | |
Principal Investigator: Jonathon Weiss, MD | |
Sub-Investigator: Joel Shavin, MD | |
Sub-Investigator: W. Stephen Steiner, PA | |
United States, Illinois | |
Christie Clinic | Recruiting |
Champaign, Illinois, United States, 61820 | |
Contact: Paula Phillips 217-366-1327 | |
Principal Investigator: Lester Fahrner, MD | |
Sub-Investigator: Gina Bird, PA-C | |
Sub-Investigator: Eleni Moriates, PA-C | |
Scott D. Glazer, M.D., S.C. | Recruiting |
Buffalo Grove, Illinois, United States, 60089 | |
Contact: Scott D Glazer, M.D., S.C. 847-459-6611 | |
Principal Investigator: Scott D Glazer, M.D., S.C. | |
United States, New York | |
Long Island Skin Cancer and Dermatologic Surgery, PC | Recruiting |
Smithtown, New York, United States, 11787 | |
Contact: Marcia Hollander, B.S. comp. ed. systems (631) 864-6647 m7395@optonline.net | |
Principal Investigator: Daniel Siegel, M.D. | |
Sub-Investigator: Anthony Wong, M.D. | |
Sub-Investigator: Darren Mollick, M.D. | |
Sub-Investigator: Dennis Nguyen, M.D. | |
Sub-Investigator: Marcia Hollander, B.S. | |
United States, Oregon | |
Oregon Dermatology and Research Center | Recruiting |
Portland, Oregon, United States, 97210 | |
Contact: Bernie Severson, CCRC 503-226-3376 BGseverson@cs.com | |
Principal Investigator: Phoebe Rich, MD | |
Sub-Investigator: Amy Simpson, PA-C | |
United States, Texas | |
Dermatology Clinical Research Center of San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Janice K Orem, CMA 210-692-1382 | |
Contact: Steven A Davis, MD (210) 614-3355 | |
Sub-Investigator: Joey D Dixon | |
Principal Investigator: Steven A Davis, M.D. | |
Sub-Investigator: Glenda L Bruce, RN, MSN | |
Sub-Investigator: Gloria J Johnson | |
Sub-Investigator: Janice K Orem, CMA | |
Sub-Investigator: Arthur W Richardson, M.D. | |
United States, Virginia | |
Education & Research Foundation | Recruiting |
Lynchburg, Virginia, United States, 24501 | |
Contact: Julie Doyle 434-847-8400 ext 101 | |
Sub-Investigator: Kappa Meadows, MD | |
Principal Investigator: David Wilson, MD |
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: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00604890 |
Health Authority: | United States: Food and Drug Administration |
Double-Blind Placebo Topical |
Treatment Dose-Ranging sBCC |
Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell |