Human evidence record · Melanotan II
Pilot Phase I melanotan II human study
Pigmentation increased in all three volunteers.
Quick read
Human evidence record
What this study tells us
This was an early human study designed mainly to measure exposure, tolerability or a preliminary signal. Without stronger blinded controls, it should not be treated as definitive proof of benefit.
Who was studied?
Healthy male volunteers
How many?
n=3
What happened?
Pigmentation increased in all three volunteers.
What stops us overclaiming?
Only three participants; does not establish long-term safety or an approved tanning regimen.
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Key result
Pigmentation increased in all three volunteers.
Study details
Study designPhase I pilot
PhasePhase I
PopulationHealthy male volunteers
Sample size3
RouteSubcutaneous
Regimen / exposure0.01 mg/kg escalating to 0.025-0.03 mg/kg
DurationShort dose-escalation exposure
ComparatorWithin-subject baseline
Primary endpoint / questionPigmentation / melanogenic activity
Safety resultNausea, yawning/stretching, spontaneous erections, somnolence/fatigue reported.
Key limitationsOnly three participants; does not establish long-term safety or an approved tanning regimen.
Registry / identifierPMID 8637402
Evidence verified2026-09-18