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Study · Non-randomized trial · n = 2 · 2014

4 results

Efficacy of the melanocortin analogue Nle4-D-Phe7-α-melanocyte-stimulating hormone in the treatment of patients with Hailey-Hailey disease.

Biolcati G, Aurizi C, Barbieri L, Cialfi S, Screpanti I, Talora C

Clinical and experimental dermatology25 Oct 2013Cited by 27 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 2 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In two patients with Hailey-Hailey disease, Short Form-36 scores improved 30 days after the first afamelanotide injection.

    In plain wordsIn two people with Hailey-Hailey disease, quality of life scores improved after afamelanotide, with no control group.

    Outcome
    IncreaseShort Form-36 score 30 days after first injection
    Study

    n = 2

    Outcome group
    Quality of life · Skin and wound
    Studied dose
    16 mg · subcutaneous implantAs given in this study (human).

    Source sentences

    Summary
    For both patients, their scores on the Short Form-36 improved 30 days after the first injection of afamelanotide
    1 context sentence
    Summary · context
    In a phase II open-label pilot study, afamelanotide 16 mg was administered subcutaneously as a sustained-release resorbable implant formulation to two patients with HHD, who had a number of long-standing skin lesions.
  2. 02HumanNon-randomized trialEfficacy outcome

    In two patients with Hailey-Hailey disease, both had 100% clearance of lesions 60 days after the first afamelanotide injection.

    In plain wordsIn two people with Hailey-Hailey disease, skin lesions cleared completely after afamelanotide, with no control group.

    Outcome
    DecreaseClearance of HHD lesions 60 days after first injection
    Study

    n = 2

    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    16 mg · subcutaneous implantAs given in this study (human).

    Measurements

    Lesion clearance
    100%
    both patients, 60 days

    Source sentences

    Summary
    both had 100% clearance of HHD lesions 60 days after the first injection, independently of the lesion location.
    1 context sentence
    Summary · context
    In a phase II open-label pilot study, afamelanotide 16 mg was administered subcutaneously as a sustained-release resorbable implant formulation to two patients with HHD, who had a number of long-standing skin lesions.
  3. 03LabIn vitro (cells)Mechanism

    In keratinocytes derived from Hailey-Hailey disease lesions, afamelanotide upregulated the redox-sensitive transcription factor Nrf2.

    In plain wordsIn skin cells from Hailey-Hailey disease lesions, afamelanotide raised Nrf2, a protein that helps cells handle oxidative stress.

    Outcome
    IncreaseNrf2 expression in HHD-derived keratinocytes
    Study

    humann: not reported in source

    Hailey-Hailey disease lesion-derived keratinocytes
    Outcome group
    Receptor activity and mechanism · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Treatment of HHD-derived keratinocytes with afamelanotide contributed to upregulation of Nrf2 [nuclear factor (erythroid-derived 2)-like 2], a redox-sensitive transcription factor that plays a pivotal role in redox homeostasis during oxidative stress.
    1 context sentence
    Summary · context
    Given the significance of oxidative stress in HHD, we investigated the potential effects of the antioxidant properties of an α-MSH analogue, Nle4-D-Phe7-α-MSH (afamelanotide), in HHD lesion-derived keratinocytes.
  4. 04LabIn vitro (cells)Mechanism

    In keratinocytes derived from Hailey-Hailey disease lesions, afamelanotide restored the defective proliferative capability.

    In plain wordsIn skin cells from Hailey-Hailey disease lesions, afamelanotide restored the cells' reduced ability to multiply.

    Outcome
    IncreaseProliferative capability of HHD-derived keratinocytes
    Study

    humann: not reported in source

    Hailey-Hailey disease lesion-derived keratinocytes
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Additionally, afamelanotide treatment restored the defective proliferative capability of lesion-derived keratinocytes.
    1 context sentence
    Summary · context
    Given the significance of oxidative stress in HHD, we investigated the potential effects of the antioxidant properties of an α-MSH analogue, Nle4-D-Phe7-α-MSH (afamelanotide), in HHD lesion-derived keratinocytes.

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

Subjects

Terms as the source lists them.

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