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Study · Non-randomized trial · n = 15 · 2021

5 results

Clinical and dermoscopic changes of acquired melanocytic nevi of patients treated with afamelanotide.

Arisi M, Rossi M, Rovati C, Tomasi C, Mori L, Laini L, Calzavara-Pinton PG

Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology17 Feb 2021Cited by 3 (Europe PMC)

PMID33721252 (opens in a new tab)DOI10.1007/s43630-021-00020-2 (opens in a new tab)PepBankPUB-33721252
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Summary

BackgroundAfamelanotide (AFA) is a synthetic analogue of α-melanocyte-stimulating hormone that is approved for the treatment of patients affected by erythropoietic protoporphyria (EPP). AFA induces a "sun free" tanning and changes of acquired melanocytic nevi (AMN) that are generically described as "darkening".ObjectivesTo assess clinical and dermoscopic AMN changes during AFA treatment.MethodsAdult EPP patients treated with two AFA implants 50 days apart were enrolled. They underwent a clinical and dermoscopic examination of all AMN at baseline (T0), and after 5 (T1) and 12 (T2) months from the first AFA implant. The general pattern, symmetry, number, and size of pigmented globules, morphology of the pigment network, and dermoscopic melanoma features were assessed.ResultsFifteen patients were enrolled with 103 AMN. At T1 all reticular and 2-component AMN showed a focal network thickening that returned to baseline by T2. The increase of globules' number was observed at T1 but not at T2. The difference in number was not influenced by patients' age or phototype. Dermoscopic changes suggestive of malignancy were never seen. The development of new AMN was never registered.ConclusionsAFA treatment induces reversible changes of AMN dermoscopic morphology without findings suggestive of malignant transformation and it does not stimulate the development of new AMN.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In adults with erythropoietic protoporphyria treated with afamelanotide, all reticular and 2-component nevi showed a focal network thickening at 5 months that returned to baseline by 12 months.

    In plain wordsIn people with EPP given afamelanotide, nevi showed a temporary change in pattern at 5 months that returned to baseline by 12 months.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    IncreaseFocal network thickening of nevi at T1
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated · implant · two implants 50 days apartAs given in this study (human).

    Source sentences

    Summary
    At T1 all reticular and 2-component AMN showed a focal network thickening that returned to baseline by T2.
    2 context sentences
    Summary · context
    Adult EPP patients treated with two AFA implants 50 days apart were enrolled.
    Summary · context
    They underwent a clinical and dermoscopic examination of all AMN at baseline (T0), and after 5 (T1) and 12 (T2) months from the first AFA implant.
  2. 02HumanNon-randomized trialEfficacy outcome

    In adults with erythropoietic protoporphyria treated with afamelanotide, the number of globules in nevi increased at T1 but not at T2.

    In plain wordsIn people with EPP given afamelanotide, the number of globules in nevi rose at 5 months but not at 12 months.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    IncreaseNumber of dermoscopic globules in nevi
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated · implant · two implants 50 days apartAs given in this study (human).

    Source sentences

    Summary
    The increase of globules' number was observed at T1 but not at T2.
    2 context sentences
    Summary · context
    Adult EPP patients treated with two AFA implants 50 days apart were enrolled.
    Summary · context
    They underwent a clinical and dermoscopic examination of all AMN at baseline (T0), and after 5 (T1) and 12 (T2) months from the first AFA implant.
  3. 03HumanNon-randomized trialOther

    In adults with erythropoietic protoporphyria treated with afamelanotide, the difference in globule number was not influenced by patients' age or phototype.

    In plain wordsIn people with EPP given afamelanotide, the change in nevi globules did not depend on age or skin type.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    No significant changeInfluence of age and phototype on globule number change
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Pigmentation · Skin and wound
    Studied dose
    Dose not stated · implant · two implants 50 days apartAs given in this study (human).

    Source sentences

    Summary
    The difference in number was not influenced by patients' age or phototype.
    2 context sentences
    Summary · context
    Adult EPP patients treated with two AFA implants 50 days apart were enrolled.
    Summary · context
    They underwent a clinical and dermoscopic examination of all AMN at baseline (T0), and after 5 (T1) and 12 (T2) months from the first AFA implant.
  4. 04HumanNon-randomized trialSafety outcome

    In adults with erythropoietic protoporphyria treated with afamelanotide, dermoscopic changes suggestive of malignancy were never seen.

    In plain wordsIn people with EPP given afamelanotide, no nevus changes suggestive of cancer were seen.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    No significant changeDermoscopic changes suggestive of malignancy
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated · implant · two implants 50 days apartAs given in this study (human).

    Source sentences

    Summary
    Dermoscopic changes suggestive of malignancy were never seen.
    2 context sentences
    Summary · context
    Adult EPP patients treated with two AFA implants 50 days apart were enrolled.
    Summary · context
    They underwent a clinical and dermoscopic examination of all AMN at baseline (T0), and after 5 (T1) and 12 (T2) months from the first AFA implant.
  5. 05HumanNon-randomized trialSafety outcome

    In adults with erythropoietic protoporphyria treated with afamelanotide, the development of new nevi was never registered.

    In plain wordsIn people with EPP given afamelanotide, no new nevi were recorded.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    No significant changeDevelopment of new nevi
    Study

    n = 15

    Comparator
    Baseline
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated · implant · two implants 50 days apartAs given in this study (human).

    Source sentences

    Summary
    The development of new AMN was never registered.
    2 context sentences
    Summary · context
    Adult EPP patients treated with two AFA implants 50 days apart were enrolled.
    Summary · context
    They underwent a clinical and dermoscopic examination of all AMN at baseline (T0), and after 5 (T1) and 12 (T2) months from the first AFA implant.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    13 Oct 2026, 21:44 UTC

    Study results updated

  2. Version 1

    13 Oct 2026, 16:31 UTC

    First added · source update from Europe PMC

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