Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer

Last updated: January 29, 2009
Sponsor: US Department of Veterans Affairs
Overall Status: Completed

Phase

3

Condition

Skin Cancer

Carcinoma

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT00007631
402
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria: Exclusion criteria would include systemic retinoid treatment or systemic chemotherapywithin the past six months; indices of very high mortality risk within 3 years (history ofinvasive noncutaneous malignancy within the past five years or metastatic cutaneousmalignancy, or of other severe medical problems e.g. end-stage cardiac disease); knownallergy or severe irritation reaction to tretinoin or the cream vehicle; special conditionspredisposing to NMSC that may not be generally applicable (xeroderma pigmentosum, basalcell nevus syndrome, major organ transplant recipient, known arsenic exposure, PUVAphotochemotherapy, mycosis fungoides, or prior or current radiation therapy involving theface, ears, or area of prior skin cancer), and likely inability to comply with therequirements of the trial as judged by the investigator. Incompetent patients and pregnantor nursing patients will be excluded

Study Design

Total Participants: 1131
Study Start date:
March 01, 1998
Estimated Completion Date:
July 31, 2006

Study 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

Connect with a study center

  • Carl T. Hayden VA Medical Center

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • VA Medical Center, Long Beach

    Long Beach, California 90822
    United States

    Site Not Available

  • VA Medical Center, Miami

    Miami, Florida 33125
    United States

    Site Not Available

  • Edward Hines, Jr. VA Hospital

    Hines, Illinois 60141-5000
    United States

    Site Not Available

  • VA Medical Center, Durham

    Durham, North Carolina 27705
    United States

    Site Not Available

  • VA Medical Center, Oklahoma City

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • VA Medical Center, Providence

    Providence, Rhode Island 02908
    United States

    Site Not Available

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