MT-1 / MELANOTAN I CLINICAL STUDIES

Melanotan 1 Clinical Trials: The Afamelanotide Data

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What the SCENESSE studies tested — and what they didn't

Melanotan 1 clinical trials were conducted under the pharmaceutical name afamelanotide, and supported the approval of SCENESSE for a rare light-sensitivity disorder. This page covers the study evidence; for legal status see melanotan 1's regulatory status.

The EPP Trials

Afamelanotide was studied in randomized controlled trials involving adults with erythropoietic protoporphyria (EPP), a rare disorder in which sunlight causes severe skin pain. Across the pivotal studies, roughly 244 adults were evaluated, and the trials measured the amount of pain-free time participants could spend in light.

Source: FDA Drug Trials Snapshots: SCENESSE.

What the Studies Did Not Test

These trials tested a clinician-administered implant for a rare disease — not cosmetic tanning, and not injectable research-labeled "MT-1." The evidence does not transfer to those uses.

Frequently Asked Questions

What condition did melanotan 1 trials study?

Erythropoietic protoporphyria (EPP), a rare light-sensitivity disorder.

Did the trials study tanning?

No. They measured pain-free light exposure in EPP, not cosmetic tanning.

The Bottom Line

The melanotan 1 clinical trials are legitimate but narrow — focused on a rare disease and a specific implant, which is the honest read on melanotan 1 clinical trials.

Medical Disclaimer

This article is for general educational purposes only. It is not medical advice and should not be used to diagnose, treat, or make decisions about any health condition or medication.

Primary Sources

  • FDA prescribing information for SCENESSE
  • FDA Drug Trials Snapshots: SCENESSE

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