RCTNCT00829192Phase 2 · 2007 · n=200 · Clinuvel Pharmaceuticals Limited Actinic Keratoses
tested To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands
result In progress (unknown)
RCTNCT00979745Phase 3 · 2009 · n=74 · Clinuvel Pharmaceuticals Limited Erythropoietic Protoporphyria
tested The Duration of Direct Sunlight Exposure Between 10:00 and 15:00 Hours on Days When Patients Did Not Report Phototoxicity-related Pain (Likert Pain Scale Score of 0)
result +5.3 Hours (The Duration of Direct Sunlight Exposure Between 1…)
RCTNCT01097044Phase 2 · 2010 · n=77 · Clinuvel Pharmaceuticals Limited Erythropoietic Protoporphyria
tested Time in Direct Sunlight Between 10:00-15:00 on Pain-free Days
result +7.5 Hours (Time in Direct Sunlight Between 10:00-15:00 on Pai…)
RCTNCT01382589Phase 2 · 2011 · n=15 · Clinuvel Pharmaceuticals Limited Vitiligo
tested To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
result Completed; results not posted
Small sample; effect at the edge of clinical significance.
RCTNCT01430195Phase 1 · 2011 · n=56 · Clinuvel Pharmaceuticals Limited Vitiligo
tested Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores
result Completed; results not posted
RCTNCT01605136Phase 3 · 2012 · n=93 · Clinuvel Pharmaceuticals Limited Erythropoietic Protoporphyria
tested Duration of Direct Sunlight Exposure Between 10:00 and 18:00 Hours on Days When no Pain Was Experienced (Pain Score of 0).
result +28.6 hours (Duration of Direct Sunlight Exposure Between 10:00…)
RCTNCT03634137Phase 1 · 2009 · n=24 · Clinuvel Pharmaceuticals Limited Pharmacokinetic / healthy volunteer studies
tested Change in skin melanin density
result Completed; results not posted
Small sample; effect at the edge of clinical significance.
RCTNCT04053270Phase 3 · 2007 · n=100 · Clinuvel Pharmaceuticals Limited Erythropoietic Protoporphyria
tested Cumulative Number of Days of Phototoxic Reactions (Study Efficacy Population)
result −6.0 Days (Cumulative Number of Days of Phototoxic Reactions …)
RCTNCT04425746Phase 2 · 2008 · n=16 · Clinuvel Pharmaceuticals Limited Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
tested The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
Small sample; effect at the edge of clinical significance.
RCTNCT04525157Phase 2 · 2014 · n=21 · Clinuvel Pharmaceuticals Limited Vitiligo
tested Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Small sample; effect at the edge of clinical significance.
RCTNCT04704713Phase 3 · 2010 · n=31 · Clinuvel Pharmaceuticals Limited Polymorphic Light Eruption
tested Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale
result −0.2 score on a scale (Severity of PLE Related Pruritus Recorded Using an…)
RCTNCT04943159Phase 2 · 2010 · n=3 · Clinuvel Pharmaceuticals Limited Acne Vulgaris
tested The Change in Number of Facial Inflammatory Acne-related Lesions.
Small sample; effect at the edge of clinical significance.
Vitiligo
tested Percentage of patients achieving T-VASI 50 on the body
result In progress (active-not-recruiting)
ObseNCT004729012007 · n=18 · Clinuvel Pharmaceuticals Limited Polymorphic Light Eruption (PLE)
tested To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE
result Completed; results not posted
Small sample; effect at the edge of clinical significance.
OpenNCT00859534Phase 2 · 2008 · n=5 · Clinuvel Pharmaceuticals Limited Solar Urticaria
tested To determine whether a CUV1647 (synthetic alpha-MSH analogue) bioresorbable implant can reduce the susceptibility of patients with Solar Urticaria to provocation with a standardized light source (measured as a change in minimum urticarial dose, (MUD)).
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT04578496Phase 3 · 2011 · n=16 · Clinuvel Pharmaceuticals Limited Erythropoietic Protoporphyria
tested Change in Quality of Life Measured Using the EPP-quality of Life Questionnaire (EPP-QoL).
Non-randomised; effect size cannot be separated from placebo.
OpenNCT04962503Phase 2 · 2021 · n=6 · Clinuvel Pharmaceuticals Limited Arterial Ischemic Stroke
tested Changes in Volume of Infarct
Non-randomised; effect size cannot be separated from placebo.
OpenNCT05159752Phase 2 · 2021 · n=6 · Clinuvel Europe Limited Xeroderma Pigmentosum
tested Change in minimal erythema dose (MED).
result In progress (unknown)
Non-randomised; effect size cannot be separated from placebo.
Vitiligo
tested Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
result In progress (unknown)
Non-randomised; effect size cannot be separated from placebo.
OpenNCT05368857Phase 1 · 2022 · n=10 · Clinuvel (UK) Ltd. Pharmacokinetic / healthy volunteer studies
tested Change in UV photoproduct levels in UVR-exposed skin.
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT05370235Phase 2 · 2022 · n=6 · Clinuvel Europe Limited Xeroderma Pigmentosum
tested Change in minimal erythema dose (MED) in patients with XP-C.
result In progress (unknown)
Non-randomised; effect size cannot be separated from placebo.
OpenNCT05854784Phase 2 · 2023 · n=6 · Clinuvel Pharmaceuticals Limited Variegate Porphyria
tested The Change in Disease Severity in Patients With VP as Measured by CGIC.
Non-randomised; effect size cannot be separated from placebo.
OpenNCT06388642Phase 1 · 2024 · n=28 · Clinuvel Europe Limited Erythropoietic Protoporphyria
tested Cmax (Maximum Plasma Concentration)
Non-randomised; effect size cannot be separated from placebo.
Treatment studies
tested quality of life score, phototoxic burn tolerance time, and reaction incidence
result QoL median rose from 11.11 to 79.17; PBTT median rose from 15 min to 250 min; phototoxic reaction prevalence fell from 88% to 33%.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Preclinical / mechanistic research
tested mouse · Moderate Static Magnetic Field Promotes Osteoporotic Fracture Healing in OVX Mice by Enhancing Bone Remodeling and Regulating Iron Metabolism
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rabbit · Identification of Bivalent Ligands with Melatonin Receptor Agonist and Fatty Acid Amide Hydrolase (FAAH) Inhibitory Activity That Exhibit Ocular Hypotensive Effect in the Rabbit.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Combined Effects of Low-Frequency Pulsed Electromagnetic Field and Melatonin on Ovariectomy-Induced Bone Loss in Mice.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Agomelatine decreases cocaine-induced locomotor sensitisation and dopamine release in rats.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Methods to Assess Melatonin Receptor-Mediated Phase-Shift and Re-entrainment of Rhythmic Behaviors in Mouse Models.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Melatonin regulates the circadian rhythm to ameliorate postoperative sleep disorder and neurobehavioral abnormalities in aged mice.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Design of a 1 × 4 micro-magnetic stimulation device and its targeted, coordinated regulation on LTP of Schaffer-CA1 in the hippocampus of rats.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Melatonin Induces Analgesic Effects through MT(2) Receptor-Mediated Neuroimmune Modulation in the Mice Anterior Cingulate Cortex.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested animal model · Editorial Expression of Concern: The aqueous extract of Artemisia Absinthium L. stimulates HO-1/MT-1/Cyp450 signaling pathway via oxidative stress regulation induced by aluminium oxide nanoparticles (α and γ) animal model.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Gender-Dependent Effect of Progesterone on the Expression of Metallothionein Genes in Rat Inguinal Adipose Tissue.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Banxia Shumi Decoction Improves Sleep and Neural Function in Insomnia Male Rats via BDNF/TrkB/CREB-Dependent Melatonin Signaling Activation.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Neurotoxicity of acrylamide in wild-type and TNF-α depletion mice: possible alternative role of IL-6 and dipolar effects of TNF-α depletion on oxidative stress pathway.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested In-vitro and in-vivo assessment of the anti-diabetic, analgesic, and anti-inflammatory potenstials of metal-based carboxylates derivative
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Low-dose exposure to black carbon significantly increase lung injury of cadmium by promoting cellular apoptosis.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested <i>In-vitro</i> and <i>in-vivo</i> assessment of the anti-diabetic, analgesic, and anti-inflammatory potenstials of metal-based carboxylates derivative.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Heterogeneity of HTLV-1 proviral integration sites and internal structures in the ATL cell line MT-1.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.