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A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
Plain-language guide to NCT04578496: phase 3 interventional trial of Melanotan I, 16 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04578496
- Phase
- phase 3
- Status
- completed
- Start
- 2011-07-11
- Completion (planned or actual)
- 2014-02-27
- Participants
- 16 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Erythropoietic Protoporphyria
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Melanotan I.
It had 1 arm (groups): Afamelanotide (experimental).
The registry classes the interventions as drug.
Who Took Part
16 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female subjects with a positive diagnosis of EPP who successfully completed the CUV017 or CUV029 studies;. Aged 18-75 years (inclusive);. Provide written informed patient consent prior to the performance of any study-specific procedure.
The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: any serious adverse event considered to be related to afamelanotide or the polymer contained in the implant;; any allergy to lignocaine or other local anaesthetic to be used during the administration of the study medication;; personal history of melanoma or dysplastic nevus syndrome;.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Melanotan I study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-07-11 with completion listed for 2014-02-27.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Quality of Life Measured Using the EPP-quality of Life Questionnaire (EPP-QoL) (time frame: Baseline, Day 60, Day 120, Day 180 or early termination (ET) (if applicable)). Change in Quality of Life Measured Using the Dermatology Life Quality Index Questionnaire (DLQI) (time frame: Baseline, Day 60, Day 120, Day 180 or early termination (ET) (if applicable)).
What This Means in Plain Language
Put simply, this is a phase 3 trial of Melanotan I in 16 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Melanotan I compound page, all human trials.
Our Notes on the Compound
Melanotan I: A synthetic melanotropin (α-MSH analog), afamelanotide, studied for pigmentation; the approved product is an implant.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.