Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer
NCT ID: NCT00007631
Last Updated: 2009-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1131 participants
INTERVENTIONAL
1998-03-31
2006-07-31
Brief Summary
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Detailed Description
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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.
Weinstock, M.A., Bingham, S.F., Cole, G.W., Eilers, D., Naylor, M.F., Kalivas, J., Taylor, J.R., Gladstone, H.B., Piacquadio, D.J., and DiGiovanna, J.J. Reliability of Counting Actinic Keratoses Before and After Brief Consensus Discussion. Arch Dermatol 137:1055-1058, 2001
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Topical Tretinoin
Tretinoin 0.1% cream or placebo
2
Placebo
Placebo
Patients receive placebo for same amount of time
Interventions
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Tretinoin 0.1% cream or placebo
Placebo
Patients receive placebo for same amount of time
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Ortho Dermatologics
INDUSTRY
US Department of Veterans Affairs
FED
Responsible Party
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Department of Veterans Affairs
Principal Investigators
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Martin A. Weinstock, MD
Role: STUDY_CHAIR
VA Medical Center, Providence
Locations
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Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
VA Medical Center, Long Beach
Long Beach, California, United States
VA Medical Center, Miami
Miami, Florida, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States
VA Medical Center, Durham
Durham, North Carolina, United States
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States
VA Medical Center, Providence
Providence, Rhode Island, United States
Countries
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References
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Weinstock MA, Bingham SF, Lew RA, Hall R, Eilers D, Kirsner R, Naylor M, Kalivas J, Cole G, Marcolivio K, Collins J, Digiovanna JJ, Vertrees JE; Veterans Affairs Topical Tretinoin Chemoprevention (VATTC) Trial Group. Topical tretinoin therapy and all-cause mortality. Arch Dermatol. 2009 Jan;145(1):18-24. doi: 10.1001/archdermatol.2008.542.
Dore DD, Lapane KL, Trivedi AN, Mor V, Weinstock MA. Association between statin use and risk for keratinocyte carcinoma in the veterans affairs topical tretinoin chemoprevention trial. Ann Intern Med. 2009 Jan 6;150(1):9-18. doi: 10.7326/0003-4819-150-1-200901060-00004.
Other Identifiers
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402
Identifier Type: -
Identifier Source: org_study_id