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Robert T. Dorr, PhD; Gregory Ertl, MD; Norman Levine, MD; Chris Brooks, CCRC; Jerry L. Bangert, MD; Marianne Broome Powell, PhD; Stuart Humphrey, PhD; David S. Alberts, MD

Arch Dermatol. 2004;140:827-835.

Objective  Three phase 1 clinical trials of a superpotent melanotropic peptide, melanotan-1 (MT-1, or [Nle⁴-D-Phe⁷]-melanocyte-stimulating hormone) were performed to demonstrate safety for MT-1 therapy combined with UV-B light or sunlight.

Design  Open-label studies at 2 dose levels of MT-1 combined with small doses of UV-B to the neck or buttock or full sunlight to half of the back.

Setting  Dermatology clinics at the Arizona Health Sciences Center, Tucson.

Interventions  The first study randomized 4 subjects to MT-1 (0.08 mg/kg per day subcutaneously) and 4 subjects to injections of isotonic sodium chloride (9%) solution for 10 days, followed by neck irradiation with 3 times the minimal erythema dose (MED) of UV-B light. In the next study (n = 12), the MT-1 dosage was increased to 0.16 mg/kg per day for 10 days, with UV-B radiation (0.25-0.75 MED) given to a buttock site for 5 days during (n = 7) or after (n = 5) MT-1 administration. A final study randomized 8 subjects to 3 to 5 days of sunlight to half of the back or to sunlight plus 0.16 mg/kg of MT-1 for 5 days per week for 4 weeks.

Results  Tanning in the first study was achieved in 3 of 4 subjects receiving MT-1, and these subjects also had 47% fewer sunburn cells at the irradiated neck site. More skin sites darkened with the higher dose of MT-1 in the second study. In the third study, there was significantly enhanced tanning of the back in the MT-1 group, and this was maintained at least 3 weeks longer than the tanning in the sunlight-only controls, who required 50% more sun-exposure time for equivalent tanning.

Main Outcome Measure  There were no pathologic findings at any UV-B or sun-exposed sites in any subject. Toxic effects due to MT-1 were minor, consisting of nausea and transient facial flushing.

Conclusion  Melanotan-1 can be safely combined with UV-B light or sunlight and appears to act synergistically in the tanning response to light.

From the Department of Medicine, Cancer Center Division (Drs Dorr, Powell, and Alberts, and Ms Brooks), and Dermatology Section (Drs Ertl, Levine, and Bangert), University of Arizona, Tucson; Department of Radiation Oncology, Stanford University, Stanford, Calif (Dr Powell); and EpiTan Ltd, Melbourne, Australia (Dr Humphrey). Dr Ertl in now with Palm Canyon Dermatology, Yuma, Ariz. Dr Dorr is a consultant to EpiTan Ltd, and Drs Alberts, Dorr, and Levine are shareholders in EpiTan Ltd.

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