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.

Condition	Treatment or Intervention	Phase
nonmelanoma skin cancer	Drug: Tretinoin 0.1% cream or placebo	Phase III

Further Study Details: 

Expected Total Enrollment:  900

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.

Genders Eligible for Study:  Both

Criteria

High risk individuals (at least 2 NMSC?S in last 5 years).

Arizona
      VAMC Phoenix, Phoenix,  Arizona,  85012,  United States
California
      Vamc - West Los Angeles, Ca, Los Angeles,  California,  90024,  United States
      Vamc - Long Beach, Ca, Long Beach,  California,  90822,  United States
Florida
      Vamc - Miami, Fl, Miami,  Florida,  33125-1624,  United States
Illinois
      Vamc - Hines, Il, Maywood,  Illinois,  60153,  United States
North Carolina
      Vamc-Durham, Nc, Durham,  North Carolina,  27710,  United States
Oklahoma
      Vamc - Oklahoma City, Ok, Oklahoma City,  Oklahoma,  73104,  United States

Study ID Numbers:  402
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  December 29, 2000
ClinicalTrials.gov Identifier:  NCT00007631
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08