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Afamelanotide in Patients Suffering With Acne Vulgaris
Plain-language guide to NCT04943159: phase 2 randomized trial of Melanotan I, acne, 3 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04943159
- Phase
- phase 2
- Status
- completed
- Start
- 2010-08-24
- Completion (planned or actual)
- 2011-03-08
- Participants
- 3 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Acne Vulgaris
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Melanotan I for acne.
This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.
It had two arms (groups): Afamelanotide group A (experimental) and Afamelanotide group B (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 3 actual participants took part.
It was open to men only aged from 18 years up to 30 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3;. Chronic course of acne vulgaris;. Acne-related lesions both on the face, chest and back;. Indication for treatment of acne vulgaris;. Aged 18-30 years (inclusive);.
The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: female subjects;; diagnosis of severe acne vulgaris;; active skin disease that may interfere with evaluation;.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Melanotan I and who got the comparison, which limits bias.
The Melanotan I group and the comparison group ran side by side rather than switching.
Being open-label, the Melanotan I study did not mask who received what.
It started in 2010-08-24 with completion listed for 2011-03-08.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: The Change in Number of Facial Inflammatory Acne-related Lesions (time frame: From baseline to Day 56).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Melanotan I in 3 people with acne.
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, Acne research.
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.