Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Skin Neoplasms
Intervention: Tretinoin 0.1% cream or placebo (Drug); Placebo (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Martin A. Weinstock, MD, Study Chair, Affiliation: VA Medical Center, Providence
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Long term effect of topical tretinoin on the prevalence of premalignant actinic keratoses
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:
Inclusion Criteria:
High risk individuals (at least 2 NMSC?S in last 5 years).
Exclusion Criteria:
Exclusion criteria would include systemic retinoid treatment or systemic chemotherapy
within the past six months; indices of very high mortality risk within 3 years (history of
invasive noncutaneous malignancy within the past five years or metastatic cutaneous
malignancy, or of other severe medical problems e. g. end-stage cardiac disease); known
allergy or severe irritation reaction to tretinoin or the cream vehicle; special
conditions predisposing to NMSC that may not be generally applicable (xeroderma
pigmentosum, basal cell nevus syndrome, major organ transplant recipient, known arsenic
exposure, PUVA photochemotherapy, mycosis fungoides, or prior or current radiation therapy
involving the face, ears, or area of prior skin cancer), and likely inability to comply
with the requirements of the trial as judged by the investigator. Incompetent patients
and pregnant or nursing patients will be excluded
Locations and Contacts
Carl T. Hayden VA Medical Center, Phoenix, Arizona 85012, United States
VA Medical Center, Long Beach, Long Beach, California 90822, United States
VA Medical Center, Miami, Miami, Florida 33125, United States
Edward Hines, Jr. VA Hospital, Hines, Illinois 60141-5000, United States
VA Medical Center, Durham, Durham, North Carolina 27705, United States
VA Medical Center, Oklahoma City, Oklahoma City, Oklahoma 73104, United States
VA Medical Center, Providence, Providence, Rhode Island 02908, United States
Additional Information
Starting date: March 1998
Last updated: January 29, 2009
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