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Sponsored by: |
Cytotech Labs, LLC |
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Information provided by: | Cytotech Labs, LLC |
ClinicalTrials.gov Identifier: | NCT00652080 |
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell carcinoma by Compound 31510 topical cream.
Condition | Intervention | Phase |
---|---|---|
Squamous Cell Carcinoma |
Drug: API 31510 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Active Cream 3%; AM & PM
|
Drug: API 31510
Topical Cream; 3% active; AM & PM application
|
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 | Recruiting |
Hot Springs, Arkansas, United States, 71913 | |
Contact: Dow Stough, MD 501-620-4449 | |
United States, California | |
Skin Surgery Medical Group, Inc. | Recruiting |
San Diego, California, United States, 92117 | |
Contact: Kenneth Gross, MD 858-292-8641 | |
United States, New York | |
Long Island Skin Cancer and Dermatalogic Surgery, PC | Recruiting |
Smithtown, New York, United States, 11787 | |
Contact: Daniel M Siegel, M.D. 631-864-6647 | |
United States, Virginia | |
Education and Research Foundation | Recruiting |
Lynchburg, Virginia, United States, 24501 | |
Contact: David Wilson, MD 434-847-8400 ext 101 | |
Sub-Investigator: Kappa Meadows, MD |
Responsible Party: | Cytotech Labs, LLC ( Armanda Waddington/Administrative Manager ) |
Study ID Numbers: | CTL0408 |
Study First Received: | March 31, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00652080 |
Health Authority: | United States: Food and Drug Administration |
Epidermoid carcinoma Squamous cell carcinoma Carcinoma, squamous cell Neoplasms, Squamous Cell |
Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type |