Phase IIB randomized study of topical difluoromethylornithine and topical diclofenac on sun-damaged skin of the forearm

Joanne M. Jeter, Clara Curiel-Lewandrowski, Steven P. Stratton, Paul B. Myrdal, James A. Warneke, Janine G. Einspahr, Hubert G. Bartels, Michael Yozwiak, Yira Bermudez, Chengcheng Hu, Peter Bartels, David S. Alberts

Research output: Contribution to journalArticlepeer-review

14 Scopus citations


Prevention of nonmelanoma skin cancers remains a health priority due to high costs associated with this disease. Diclofenac and difluoromethylornithine (DFMO) have demonstrated chemopreventive efficacy for cutaneous squamous cell carcinomas. We designed a randomized study of the combination of DFMO and diclofenac in the treatment of sun-damaged skin. Individuals with visible cutaneous sun damage were eligible. Subjects were randomized to one of the three groups: topical DFMO applied twice daily, topical diclofenac applied daily, or DFMO plus diclofenac. The treatment was limited to an area on the left forearm, and the duration of use was 90 days. We hypothesized that combination therapy would have increased efficacy compared with single-agent therapy. The primary outcome was change in karyometric average nuclear abnormality (ANA) in the treated skin. Individuals assessing the biomarkers were blinded regarding the treatment for each subject. A total of 156 subjects were randomized; 144 had baseline and end-of-study biopsies, and 136 subjects completed the study. The ANA unexpectedly increased for all groups, with higher values correlating with clinical cutaneous inflammation. Nearly all of the adverse events were local cutaneous effects. One subject had cutaneous toxicity that required treatment discontinuation. Significantly more adverse events were seen in the groups taking diclofenac. Overall, the study indicated that the addition of topical DFMO to topical diclofenac did not enhance its activity. Both agents caused inflammation on a cellular and clinical level, which may have confounded the measurement of chemopreventive effects. More significant effects may be observed in subjects with greater baseline cutaneous damage.

Original languageEnglish (US)
Pages (from-to)128-134
Number of pages7
JournalCancer Prevention Research
Issue number2
StatePublished - Feb 2016

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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