Phase II Solar Urticaria (SU) Pilot Study

What Was Tested

This registered phase 2 trial tested Melanotan I.

Urticaria is one of the most common dermatological conditions with diverse clinical presentations and causes.

Solar urticaria (SU) is a rare subset of physical urticaria, where symptoms are induced by direct exposure of the skin to sunlight.

As little as 5 minutes of sun exposure can cause flares and whealing on exposed skin sites, accompanied by severe itching.

The registry classes the interventions as drug.

More on the Plan

Melanin, in the form of eumelanin, is a photoprotective agent.

CUV1647 (\[Nle4-D-Phe7\]-alpha-MSH) is a potent and longer lasting analogue of alpha-MSH which stimulates the production of eumelanin in the skin without the specific cell damage that usually occurs when melanin production is stimulated by UV radiation.

Who Took Part

5 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female subjects with a diagnosis of solar urticaria (confirmed by phototesting) of sufficient severity that they have requested treatment to alleviate symptoms. React to provocation with a light source. Aged 18-70 years. Fitzpatrick Skin Type I- IV. Written informed consent prior to the performance of any study-specific procedure.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: allergy to cuv1647 or the polymer contained in the implant; any co-existent photodermatosis such as polymorphic light eruption (ple), discoid lupus erythematosus (dle) or erythropoietic porphyria (epp); personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Melanotan I study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-12 with completion listed for 2009-06.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example To evaluate the safety/tolerability of CUV1647 by measuring treatment-emergent adverse events, To determine the effect of CUV1647 on melanin density at several specified body sites and To evaluate a change in the MUD between Days 30 and 60.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Melanotan I in 5 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Melanotan I compound page, all human trials.