18 and older, any sex, with Polymorphic Light Eruption. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Severity of PLE Related Pruritus Recorded Using an 11-point Likert ScalePrimary· From Day 0 to Day 120
PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus).
Group
Value
95% CI
Afamelanotide
0.25
0.0 – 1.4
Placebo
0.47
0.0 – 4.1
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT05368857 — DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
· Phase 1
· completed
NCT04962503 — A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
· Phase 2
· completed
NCT04525157 — Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
· Phase 2
· completed
NCT04578496 — A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
· Phase 3
· completed
NCT04943159 — Afamelanotide in Patients Suffering With Acne Vulgaris
· Phase 2
· completed
Other Clinuvel Pharmaceuticals Limited trials
Trials by the same sponsor.
NCT05854784 — Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
· Phase 2
· completed
NCT04962503 — A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
· Phase 2
· completed
NCT04525157 — Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
· Phase 2
· completed
NCT04578496 — A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
· Phase 3
· completed
NCT04943159 — Afamelanotide in Patients Suffering With Acne Vulgaris
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Clinuvel Pharmaceuticals Limited
Last refreshed: 19 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04704713.