Phase 1 Study of Topical Perillyl Alcohol Cream for Chemoprevention of Skin Cancer

• Published in: Nutrition and cancer 2008, Vol.60 (3), p.325-330
• Main Authors: Stratton, S.P, Saboda, K.L, Myrdal, P.B, Gupta, A, McKenzie, N.E, Brooks, C, Salasche, S.J, Warneke, J.A, Ranger-Moore, J, Bozzo, P.D
• Format: Article
• Language: English
• Subjects: Administration, Topical; Adult; anticarcinogenic activity; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Biological and medical sciences; chemoprevention; cherries; Citrus; Dermatology; Double-Blind Method; essential oils; Feeding. Feeding behavior; Female; Forearm; Fundamental and applied biological sciences. Psychology; Humans; Lavandula; Male; Medical sciences; Mentha spicata; Middle Aged; Monoterpenes - administration & dosage; Monoterpenes - adverse effects; neoplasms; plant extracts; plant-based foods; quantitative structure-activity relationships; Skin - drug effects; Skin - pathology; skin cancer; skin diseases; Skin Neoplasms - prevention & control; topical application; Treatment Outcome; Tumors; Tumors of the skin and soft tissue. Premalignant lesions; Vertebrates: anatomy and physiology, studies on body, several organs or systems
• ISSN: 0163-5581; 1532-7914
• DOI: 10.1080/01635580701840391

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.