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Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer Clinical research trials and Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer. Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer clinical trial. Human subjects often get the best healthcare possible for their Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer
Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer
For Condition: nonmelanoma skin cancer
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,Ortho Dermatologics
Synopsis: One-third of all malignancies in the United States (approximately one million cases diagnosed annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies with a topical agent free of serious side effects would confer substantial public health benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is one of the most common conditions requiring dermatologic care in the VA system. Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have unacceptable toxicity. In this study, 900 patients with a recent history of squamous cell and/or basal cell carcinoma will be enrolled at six participating centers over a three-year period and will be randomly assigned to either 0.1% tretinoin cream or placebo. They will be followed for a minimum of three years to determine if topical tretinoin is effective in reducing the risk of new occurrences.
Details: Primary Hypothesis: To determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer (NMSC) among high risk individuals (at least 2 NMSC’S in last 5 years). Secondary Hypothesis: Secondary objectives are: (a) to determine the long-term effect of topical tretinoin on the prevalence of premalignant actinic keratoses, and (b) to distinguish subpopulations in which topical tretinoin is particularly effective or ineffective, compared to the overall study population. Intervention: Apply Tretinoin 0.1% cream or placebo cream to face and ears twice a day. Primary Outcomes: New NMSC lesions on the face and ears. Number of actinic keratoses on the face and ears. Study Abstract: One-third of all malignancies in the United States (approximately one million cases diagnosed annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies with a topical agent free of serious side effects would confer substantial public health benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is one of the most common conditions requiring dermatologic care in the VA system. Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have unacceptable toxicity. In this study, 1200 patients with a recent history of squamous cell and/or basal cell carcinoma will be enrolled at six participating centers over a four-year period and will be randomly assigned to either 0.1% tretinoin cream or placebo. They will be followed for a minimum of two years to determine if topical tretinoin is effective in reducing the risk of new occurrences.
Eligibility:
Study Type: Interventional, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: High risk individuals (at least 2 NMSC?S in last 5 years).
Total Enrollment: 900
Location and Contact Information:
Vamc - Hines, Il
Maywood, Illinois, 60153
United States
VAMC Phoenix
Phoenix, Arizona, 85012
United States
Vamc - Oklahoma City, Ok
Oklahoma City, Oklahoma, 73104
United States
Vamc - Miami, Fl
Miami, Florida, 33125-1624
United States
Vamc-Durham, Nc
Durham, North Carolina, 27710
United States
Vamc - West Los Angeles, Ca
Los Angeles, California, 90024
United States
Vamc - Long Beach, Ca
Long Beach, California, 90822
United States
Additional Information:
Study ID Numbers: 402;
Study Start Date: March 1998
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007631
Other Nonmelanoma Skin Cancer Studies:
1. Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer
Related Studies:
Other nonmelanoma skin cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Determine the efficacy of topical tretinoin cream for the prevention of nonmelanoma skin cancer
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