Phase 1 study of topical perillyl alcohol cream for chemoprevention of skin cancer

Steven P Stratton, Kathy Lynn Saboda, Paul B Myrdal, Abhishek Gupta, Naja E. McKenzie, Chris Brooks, Stuart J. Salasche, James A Warneke, James Ranger-Moore, Paul D. Bozzo, James Blanchard, Janine G Einspahr, Robert T Dorr, Norman Levine, David S Alberts

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Perillyl alcohol (POH) is a natural product derived from plants such as cherry and lavendin. Previous studies have indicated that topical POH inhibits ultraviolet (UV) B-induced skin carcinogenesis in vivo, and it may be an effective chemopreventive agent for skin cancer. We performed a 1-mo, first-in-man, Phase 1 trial of topically administered POH cream in human subjects. Endpoints included safety and evaluation of any histopathological changes in skin after 1 mo use of POH cream. We randomized 25 subjects with normal, healthy skin with little or no sun damage and no history of skin cancer in a double-blind fashion to receive topical POH (0.76% wt/wt) on 1 forearm with placebo cream applied to the other forearm twice daily for 30 days. Subjects were monitored for toxicity, and a 4 mm punch biopsy in the treated area was performed at the end of study for histopathological evaluation. The topical cream was well tolerated. No serious cutaneous toxicities, systemic toxicities, or histopathological abnormalities were observed. A total of 8 subjects (32%) reported mild adverse events possibly or probably related to use of cream including reversible appearance of 1 to 2 small papules. However, there was no significant difference between lesions appearing on the POH treated forearm vs. the placebo-treated forearm.

Original languageEnglish (US)
Pages (from-to)325-330
Number of pages6
JournalNutrition and Cancer
Volume60
Issue number3
DOIs
StatePublished - May 2008

Fingerprint

perilla alcohol
chemoprevention
Chemoprevention
Skin Neoplasms
cream
alcohols
Forearm
skin (animal)
Skin
toxicity
placebos
Placebos
Solar System
Biological Products
endpoints
lesions (animal)
carcinogenesis
ultraviolet radiation
skin neoplasms
biopsy

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Oncology
  • Food Science

Cite this

Phase 1 study of topical perillyl alcohol cream for chemoprevention of skin cancer. / Stratton, Steven P; Saboda, Kathy Lynn; Myrdal, Paul B; Gupta, Abhishek; McKenzie, Naja E.; Brooks, Chris; Salasche, Stuart J.; Warneke, James A; Ranger-Moore, James; Bozzo, Paul D.; Blanchard, James; Einspahr, Janine G; Dorr, Robert T; Levine, Norman; Alberts, David S.

In: Nutrition and Cancer, Vol. 60, No. 3, 05.2008, p. 325-330.

Research output: Contribution to journalArticle

Stratton, SP, Saboda, KL, Myrdal, PB, Gupta, A, McKenzie, NE, Brooks, C, Salasche, SJ, Warneke, JA, Ranger-Moore, J, Bozzo, PD, Blanchard, J, Einspahr, JG, Dorr, RT, Levine, N & Alberts, DS 2008, 'Phase 1 study of topical perillyl alcohol cream for chemoprevention of skin cancer', Nutrition and Cancer, vol. 60, no. 3, pp. 325-330. https://doi.org/10.1080/01635580701840391
Stratton, Steven P ; Saboda, Kathy Lynn ; Myrdal, Paul B ; Gupta, Abhishek ; McKenzie, Naja E. ; Brooks, Chris ; Salasche, Stuart J. ; Warneke, James A ; Ranger-Moore, James ; Bozzo, Paul D. ; Blanchard, James ; Einspahr, Janine G ; Dorr, Robert T ; Levine, Norman ; Alberts, David S. / Phase 1 study of topical perillyl alcohol cream for chemoprevention of skin cancer. In: Nutrition and Cancer. 2008 ; Vol. 60, No. 3. pp. 325-330.
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