Home / Skin & hair / Melanotan-1 (Afamelanotide)
MeHuman trials

Melanotan-1 (Afamelanotide) protocol

Melanotan-1 is the same peptide as afamelanotide. As a 16 mg slow-release implant (Scenesse) it is approved for adults with EPP, a light-sensitivity condition. Injections for tanning are not approved.

Implant approved in the US (2019) and EU (2014) - Scenesse, only for adults with EPPTanning injections are not approved; the implant must be given by a trained health professional
ProtocolMixingResultsSide effectsHow it worksSources

The protocol at a glance

The label dose is one 16 mg implant under the skin every 2 months. The only human tanning trial I found (28 men, 1991) gave 10 injections over 12 days; the amount per injection was not in the abstract.

Product or studyAmount and schedule
Home injection dose for tanningNot established
Scenesse implant, US labelOne 16 mg implant under the skin, every 2 months
Scenesse implant, EU labelOne implant every 2 months; 3 a year advised, max 4
1991 tanning trial (28 men)10 injections over 12 days; per-injection amount not in the abstract

Sources: Scenesse US prescribing information (DailyMed), EMA Scenesse page, Levine 1991 JAMA (PMID 1658407). The implant is a slow-release depot and is not comparable to small daily injections.

Community reports

Community reports commonly describe a loading phase of 0.25-0.5 mg daily for 10-14 days.

What people say they do, collected from community discussions. Not tested in a trial; shown so you can compare it with the evidence above.

Mixing

No mixing table here: this one is used as a capsule, nasal spray or skin product, or has no human amount to calculate from. The general mixing calculator works for any vial.

What the trials found

Two placebo-controlled trials of the 16 mg implant in adults with EPP (about 93 and 74 people). Measured: pain-free time in direct sun:

64.1 hMedian pain-free sun hours, implant (US trial, 6 months)
40.5 hPlacebo (same trial)
6.0 hImplant (EU trial, 9 months)
0.75 hPlacebo (same trial)

Figures are from the US label (CUV039, CUV029). The 2015 NEJM paper (PMID 26132941) reports slightly different medians for its own analysis, for example 69.4 vs 40.8 hours in the US trial. These results are for EPP, not for tanning.

Side effects

  • Implant site reaction 21% (vs 10% placebo), nausea 19% (vs 14%), skin darkening 4% (vs 0%), darkened moles 4% (vs 2%).
  • Serious allergic reactions, including anaphylaxis, have been reported.
  • It can darken existing moles and freckles and cause overall skin darkening; the label advises a full-body skin check twice a year.
  • Safety of unregulated injectable products is not established.

How it works

Melanocortin 1 receptor (MC1R)

It copies the natural pigment hormone alpha-MSH and acts on MC1R in skin to make more dark pigment (eumelanin), without needing sun.

Sources

  • SCENESSE (afamelanotide) US prescribing information, DailyMed setid 94f53286-11dd-7fbb-e053-2a95a90a7c48
  • EMA, Scenesse EPAR (authorised 22 December 2014, exceptional circumstances)
  • Langendonk JG et al. N Engl J Med 2015, PMID 26132941
  • Levine N et al. JAMA 1991, PMID 1658407