Completed Phase I 1996

    Eumelanin and the photoprotection of skin color: linking experimental studies and clinical outcomes

    Dorr RT, Lines R, Levine N, et al.

    Journal of the American Academy of Dermatology

    DOI: 10.1016/S0190-9622(96)90346-6

    Summary

    This early clinical study evaluated the melanogenic effects of Melanotan II (MT-II), a cyclic analog of alpha-melanocyte-stimulating hormone, administered subcutaneously to human volunteers. MT-II produced significant darkening of the skin through increased eumelanin synthesis without requiring UV exposure, demonstrating the first clinical proof-of-concept for pharmacologically induced tanning.

    Key Findings

    • Subcutaneous Melanotan II (0.025 mg/kg) administered over 5 days produced measurable skin darkening as quantified by reflectance spectrophotometry
    • Melanin content analysis confirmed the pigmentation was predominantly eumelanin (photoprotective brown-black pigment) rather than pheomelanin
    • Nausea and facial flushing were the most common side effects, occurring transiently after injection and resolving within hours

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