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Human studies

Melanotan I

Human afamelanotide implant trials provide formulation-specific evidence in photosensitivity and alongside vitiligo phototherapy.

Research summary

Afamelanotide for Erythropoietic Protoporphyria.

The New England journal of medicine 2015

Langendonk JG, Balwani M, Anderson KE, Bonkovsky HL, Anstey AV, Bissell DM, Bloomer J, Edwards C, Neumann NJ, Parker C, Phillips JD, Lim HW, Hamzavi I, Deybach JC, Kauppinen R, Rhodes LE, Frank J, Murphy GM, Karstens FPJ, Sijbrands EJG, de Rooij FWM, Lebwohl M, Naik H, Goding CR, Wilson JHP, Desnick RJ

Randomised human implant trials

Pain-free sunlight exposure increased with afamelanotide implants in two blinded trials involving 168 people with erythropoietic protoporphyria. Quality-of-life measures improved, and the European trial recorded fewer phototoxic reactions. Adverse events were mostly mild. This is useful human evidence for a regulated implant in a specific condition, with formulation and population boundaries that matter when discussing Melanotan I.

View on PubMed: Afamelanotide for Erythropoietic Protoporphyria.

Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

JAMA dermatology 2015

Lim HW, Grimes PE, Agbai O, Hamzavi I, Henderson M, Haddican M, Linkner RV, Lebwohl M

Randomised multicentre human trial

Repigmentation occurred earlier and was greater with an afamelanotide implant plus narrowband UV-B than with UV-B alone in a 55-person vitiligo trial. The clearest differences were in darker skin phototypes; erythema occurred in both groups and nausea and minor infections were recorded with combination treatment. The result belongs to an implant–phototherapy combination, not to a research vial or the peptide alone.

View on PubMed: Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

Models studied

  • Melanocortin receptor pharmacology
  • Photobiology
  • Pigmentation responses
  • Controlled human trials

Key findings

  • Human evidence from a specific implant

    The human result concerns an afamelanotide implant in a defined photosensitivity condition, with formulation-specific interpretation.

  • Combination with phototherapy

    An implant combined with UV-B gave different repigmentation outcomes from UV-B alone; the combination is integral to the comparison.

References

  1. Afamelanotide for Erythropoietic Protoporphyria.

    The New England journal of medicine 2015

    Langendonk JG, Balwani M, Anderson KE, Bonkovsky HL, Anstey AV, Bissell DM, Bloomer J, Edwards C, Neumann NJ, Parker C, Phillips JD, Lim HW, Hamzavi I, Deybach JC, Kauppinen R, Rhodes LE, Frank J, Murphy GM, Karstens FPJ, Sijbrands EJG, de Rooij FWM, Lebwohl M, Naik H, Goding CR, Wilson JHP, Desnick RJ

    PMID 26132941

    View on PubMed: Afamelanotide for Erythropoietic Protoporphyria.
  2. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

    JAMA dermatology 2015

    Lim HW, Grimes PE, Agbai O, Hamzavi I, Henderson M, Haddican M, Linkner RV, Lebwohl M

    PMID 25230094

    View on PubMed: Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

For laboratory research use only. Content is provided for research reference and is not intended as medical or veterinary guidance.