Phase 1 study of topical perillyl alcohol cream for chemoprevention of skin cancer.
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.
Stratton
Steven P
SP
Arizona Cancer Center and Department of Medicine, College of Medicine, University of Arizona, Tucson, Arizona 85724, USA. sstratton@azcc.arizona.edu
Saboda
Kathy Lynn
KL
Myrdal
Paul B
PB
Gupta
Abhishek
A
McKenzie
Naja E
NE
Brooks
Chris
C
Salasche
Stuart J
SJ
Warneke
James A
JA
Ranger-Moore
James
J
Bozzo
Paul D
PD
Blanchard
James
J
Einspahr
Janine G
JG
Dorr
Robert T
RT
Levine
Norman
N
Alberts
David S
DS
D000287:Administration, Topical; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005542:Forearm; D006801:Humans; D008297:Male; D008875:Middle Aged; D039821:Monoterpenes / Q000008:administration & dosage* / Q000009:adverse effects; D012867:Skin / Q000187:drug effects* / Q000473:pathology; D012878:Skin Neoplasms / Q000517:prevention & control*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D039821:Monoterpenes; C032208:perillyl alcohol