Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Neoplasms; Carcinoma, Squamous Cell; Carcinoma, Basal Cell
Intervention: Tretinoin 0.1% cream or placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Department of Veterans Affairs
Summary
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, 1131 patients with a recent history of squamous cell
and/or basal cell carcinoma were enrolled at six participating centers over a four-year
period and were randomly assigned to either 0. 1% tretinoin cream or placebo. They were
followed for a minimum of two years to determine if topical tretinoin is effective in
reducing the risk of new occurrences.
Clinical Details
Official title: CSP #402 - VA Topical Tretinoin Chemoprevention Trial
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Detailed description:
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.
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
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
High risk individuals (at least 2 NMSC?S in last 5 years).
Locations and Contacts
Phoenix VAMC, Phoenix, Arizona 85012, United States
Long Beach, Long Beach, California 90822, United States
Miami, Miami, Florida 33125, United States
Hines, Hines, Illinois 60141, United States
Durham, Durham, North Carolina 27705, United States
Oklahoma City, Oklahoma City, Oklahoma 73104, United States
Additional Information
Starting date: March 1998
Ending date: November 2004
Last updated: February 2, 2007
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