Glossary

ALPHA-MELANOCYTE STIMULATING HORMONE (α-MSH)
A peptide hormone which activates or stimulates the production and release of (eu)melanin in the skin (melanogenesis).
DERMATOCOSMETICS
Dermatocosmetics are specially formulated products designed to assist skin health with a focus on anti-aging, and repair and regeneration of the skin. Dermatocosmetics combine a dermatological action to treat the skin and a cosmetic action to cleanse, moisturise, and alter the appearance of an individual’s skin.
EUROPEAN MEDICINES AGENCY (EMA)
The decentralised body of the European Union regulating medical drugs and devices.
EUMELANIN
A black or brown pigment mainly concerned with the protection of the skin by absorbing incoming UV radiation. This protective ability warrants melanin to be termed a photoprotectant (a substance capable of providing protection against radiation from the sun). α-MSH acts specifically to stimulate (eu)melanin synthesis.
FOOD AND DRUG ADMINISTRATION (FDA)
The USA’s regulatory agency for food, tobacco, medicines, and devices.
MELANIN
The dark pigment synthesised by melanocytes; responsible for skin pigmentation.
MELANOCORTINS
Melanocortins are a group of peptide hormones, consisting of adrenocorticotropin hormone (ACTH), α-melanocyte stimulating hormone (α-MSH), beta-melanocyte-stimulating hormone (β-MSH), and gamma-melanocyte-stimulating hormone (γ-MSH) and are derived from proopiomelanocortin (POMC) in the pituitary gland.
MELANOCORTIN RECEPTORS
Melanocortins exert their effects by binding to and activating melanocortin receptors, a family of five (MC1R to MC5R) seven-transmembrane G-protein coupled receptors (GPCRs) that affect different body functions. The receptors are widespread throughout the body, exhibiting myriad ligand affinities, tissue and cell distribution, and downstream effects.
MELANOGENESIS
The process whereby melanin is produced in the body.
NARROWBAND ULTRAVIOLET B (NB-UVB) PHOTOTHERAPY
Therapy which utilises an ultraviolet B light source to activate melanin in vitiliginous lesions of the skin.
PHASE I
The first trials of a new drug candidate in humans, Phase I trials are designed to evaluate how a new drug candidate should be administered, to identify the highest tolerable dose and to evaluate the way the body absorbs, metabolises and eliminates the drug.
PHASE II
A Phase II trial is designed to continue to test the safety of the drug candidate, and begins to evaluate whether, and how well, the new drug candidate works (efficacy). Phase II trials often involve larger numbers of patients.
PHASE IIB/PHASE III
Advanced-stage clinical trials that should conclusively demonstrate how well a therapy based on a drug candidate works. Phase III trials can be longer and typically much larger than Phase II trials, and frequently involve multiple test sites. The goal is statistically determining whether a therapy clinically improves the health of patients undergoing treatment while remaining safe and well tolerated.
PHARMACODYNAMICS
The study of the time course of a drug’s actions in the body.
PHARMACOKINETICS
The part of pharmacology that studies the release and availability of a molecule and drug in the human body.
PHOTODERMATOSES
Photodermatoses are a variety of skin conditions that develop as a result of exposure to ultraviolet radiation or visible light.
PHOTOPROTECTION
Protection from light and ultraviolet radiation. Melanin provides natural photoprotection to skin, whilst sunscreens provide artificial photoprotection.
SUBCUTANEOUS
Underneath the skin.
SUSTAINED RELEASE/CONTROLLED-RELEASE
Process whereby a drug is released from a formulation over a period of time.
THERAPEUTIC GOODS ADMINISTRATION (TGA)
Australia’s regulatory agency for medicinal products and devices.
ULTRAVIOLET (UV) RADIATION
Part of the electromagnetic spectrum at wavelengths below 400 nanometers, also called the invisible portion of light. There are three sub-types of UV: UVC <280 nm; UVB 280–320 nm; UVA 320–400 nm.

An extensive glossary of terms relevant to CLINUVEL’s work can be found at: https://www.clinuvel.com/glossary