Clinical trial to evaluate whether topical medication can prevent common skin cancer
Brown University
Backed by a $34 million
award from the U.S. Department of Veterans Affairs Cooperative
Studies Program, the study will investigate the potential of imiquimod, a
topical medication with minimal side effects, as a preventive measure against
basal cell carcinoma.
Weinstock — who is the chief of
dermatology research for the V.A. Providence Healthcare System — will lead the
trial with co-chair Dr. Robert Dellavalle, chief of dermatology for the V.A.
Eastern Colorado Health Care System and a University of Colorado School of
Medicine professor.
Basal cell carcinoma usually occurs on the face and requires surgery to avoid serious complications.
An effective
preventive medication could help many patients avoid or at least postpone the
risks of surgery, and decrease the need for medical visits and their resulting
costs, Weinstock said.
“These lesions are typically treated with what I call a ‘cut and wait’ approach,” he said, noting that skin damage and scarring are undesirable side effects. “Unfortunately, we don’t have anything better right now.”
More than 1,600 participants,
including U.S. military veterans at high risk for basal cell carcinoma, will be
recruited from 17 V.A. medical centers for the trial.
They will apply the cream to their
faces daily for up to 12 weeks and be followed actively for three years to see
if their skin cancer risk is reduced, with an additional year of passive
follow-up.
In addition to evaluating
effectiveness of the treatment, researchers will collect genetic material from
some participants to determine factors that may indicate greater risk reduction
and better tolerance of imiquimod therapy. This will help target therapy to
those who will benefit from it the most.
Weinstock said that developing ways
to actively prevent basal and squamous cell carcinoma has been a goal since he
joined the Brown faculty in 1988. He has been involved with two other national
studies directed at skin cancer therapies — one of these clinical trials found
that topical application of a cream containing 5-fluorouracil 5% reduced the
risk of squamous cell carcinoma by 75% for a year.
“There’s good reason to believe that
we’ll see in this upcoming trial that imiquimod has similar preventative
effects on BCC,” Weinstock said. And if that turns out to be the case, he said,
“it would fundamentally transform our approach to the disease – we need to
proactively prevent this cancer that afflicts millions each year.