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

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Skin Neoplasms

In brief

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.

Key facts

Study ID

NCT00007631

Run by

US Department of Veterans Affairs

People needed

1131

Starts

1998-03-01

Expected to finish

2006-07-01

Last updated by the study team

2009-01-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.