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Sponsored by: |
Cytotech Labs, LLC |
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Information provided by: | Cytotech Labs, LLC |
ClinicalTrials.gov Identifier: | NCT00605709 |
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 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 Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Active Cream 3% ; AM & PM
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Drug: API 31510 Topical Cream
Topical treatments to lesion twice daily of randomized treatments.
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2: Active Comparator
Placebo Cream AM; 3% Active Cream PM
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Drug: API 31510 Topical Cream
Topical treatments to lesion twice daily of randomized treatments.
|
3: Active Comparator
Placebo Cream AM; 1.5% Active Cream PM
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Drug: API 31510 Topical Cream
Topical treatments to lesion twice daily of randomized treatments.
|
4: Placebo Comparator
Placebo Cream AM & PM
|
Drug: API 31510 Topical Cream
Topical treatments to lesion twice daily of randomized treatments.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cytotech Labs, LLC ( Armanda Waddington/Administrative Manager ) |
Study ID Numbers: | CTL0208 |
Study First Received: | January 18, 2008 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00605709 |
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 |