Solar UrticariaPhase 2NCT00859534
Phase II Solar Urticaria (SU) Pilot Study
A Phase 2 study testing afamelanotide in people with Solar Urticaria, run by Clinuvel Pharmaceuticals Limited at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Solar Urticaria
- What is being tested?
- afamelanotide
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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.
Who cannot join
- 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.
- Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
- Diagnosed with HIV/AIDS or hepatitis.
- Any evidence of organ dysfunction or deviation from normal the clinical or laboratory determinations judged to be clinically significant by the Investigator.
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- History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine (including diabetes, Cushing's syndrome, Addison's disease, Peutz-Jeagher syndrome), neurological (including seizures), haematological (especially anaemia of less than 10 g/100 mL) or systemic disease judged to be clinically significant by the Investigator.
- Acute history of drug or alcohol abuse (in the last 12 months).
- Major medical or psychiatric illness.
- Patient assessed as not suitable for the study in the opinion of the investigator (e.g. noncompliance history, allergic to local anaesthetics, faints when given injections or giving blood).
- Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating.
- Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device).
- Sexually active men with partners of child bearing potential not using barrier contraception during the trial and for a period of three months hereafter.
- Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
- Any factors that may affect skin reflectance measurements.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal Foundation Hospital (Hope Hospital)
Manchester
About this study
Official title: A Phase II, Open Label Pilot Study to Evaluate the Safety and Efficacy of A Bioresorbable Subcutaneous Implant of CUV1647 in Patients With Solar Urticaria (SU)
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 wavelengths of radiation causing the eruption (i.e. the action spectrum) are in the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have a very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A delayed form of SU has also been reported, although this is extremely rare. Information on the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed to direct sunlight. The condition can be very distressing and severely impair the individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy, i.e. oral antihistamines, is only partially effective and may provide little worthwhile relief of symptoms.
This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining the minimum urticarial dose before and after treatment.
Read the detailed description
When human skin is exposed to ultraviolet radiation from the sun or via the use of solaria, it responds by increasing melanin levels within epidermal melanocytes. Ultraviolet light enhances the local production and release of alpha-melanocyte stimulating hormone (alpha-MSH), which results in increased melanin levels through a process known as melanogenesis. Melanin, in the form of eumelanin, is a photoprotective agent. The mechanisms proposed for photoprotection include, but are not limited to, the absorption and scattering of UV and visible radiation, free radical scavenging and quenching of UV light. There is also increasing evidence that melanogenesis represents a major antioxidant defence mechanism in melanocytes, neutralising the deleterious effects of free radicals and active oxygen species. Eumelanin acts as a neutral density filter and, unlike most sunscreens, reduces all wavelengths of light equally so that the photoprotection provided by epidermal melanin pigmentation is essentially independent of wavelength.
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.
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 wavelengths of radiation causing the eruption (i.e. the action spectrum) are in the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have a very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A delayed form of SU has also been reported, although this is extremely rare. Information on the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed to direct sunlight. The condition can be very distressing and severely impair the individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy, i.e. oral antihistamines, is only partially effective and may provide little worthwhile relief of symptoms.
This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining the minimum urticarial dose before and after treatment.
- Conditions
- Solar Urticaria
- Being tested
- afamelanotide
- Keywords
- Solar Urticaria
- Medical subject headings
- Urticaria, Solar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afamelanotideDrug
16mg afamelanotide, one dose for the duration of the clincial trial
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 60 days
Secondary outcomes (3)
To evaluate the safety/tolerability of CUV1647 by measuring treatment-emergent adverse events.
Measured: 60 days
To determine the effect of CUV1647 on melanin density at several specified body sites.
Measured: 60 days
To evaluate a change in the MUD between Days 30 and 60.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lesley Rhodes, M.D., Principal investigator, Salford Royal Foundation Hospital (Hope Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859534
- Sponsor's protocol ID
- CUV016
- Status last verified
- Sep 2009
- First submitted
- 5 Mar 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label Pilot Study to Evaluate the Safety and Efficacy of A Bioresorbable Subcutaneous Implant of CUV1647 in Patients With Solar Urticaria (SU)
- ClinicalTrials.gov ID
- NCT00859534
- Acronym / sponsor ID
- CUV016
- Conditions
- Solar Urticaria
- Keywords
- Solar Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Clinuvel Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 wavelengths of radiation causing the eruption (i.e. the action spectrum) are in the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have a very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A delayed form of SU has also been reported, although this is extremely rare. Information on the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed to direct sunlight. The condition can be very distressing and severely impair the individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy, i.e. oral antihistamines, is only partially effective and may provide little worthwhile relief of symptoms.
This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining the minimum urticarial dose before and after treatment.
Detailed description
When human skin is exposed to ultraviolet radiation from the sun or via the use of solaria, it responds by increasing melanin levels within epidermal melanocytes. Ultraviolet light enhances the local production and release of alpha-melanocyte stimulating hormone (alpha-MSH), which results in increased melanin levels through a process known as melanogenesis. Melanin, in the form of eumelanin, is a photoprotective agent. The mechanisms proposed for photoprotection include, but are not limited to, the absorption and scattering of UV and visible radiation, free radical scavenging and quenching of UV light. There is also increasing evidence that melanogenesis represents a major antioxidant defence mechanism in melanocytes, neutralising the deleterious effects of free radicals and active oxygen species. Eumelanin acts as a neutral density filter and, unlike most sunscreens, reduces all wavelengths of light equally so that the photoprotection provided by epidermal melanin pigmentation is essentially independent of wavelength.
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.
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 wavelengths of radiation causing the eruption (i.e. the action spectrum) are in the ultraviolet or visible light range. Initially described by Merklen in 1904, SU may have a very sudden and dramatic onset, and then rapidly disappear once the exposure ceases. A delayed form of SU has also been reported, although this is extremely rare. Information on the pathophysiology of SU is limited and symptoms are confined to areas of the body exposed to direct sunlight. The condition can be very distressing and severely impair the individual's ability to go outdoors and to tolerate indoor lighting. The standard therapy, i.e. oral antihistamines, is only partially effective and may provide little worthwhile relief of symptoms.
This pilot study is proposed to evaluate implants containing 16mg CUV1647 as a prophylactic treatment for patients with SU. The effectiveness of CUV1647 will be assessed by determining the minimum urticarial dose before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
- Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
- Diagnosed with HIV/AIDS or hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| afamelanotide16mg afamelanotide, one dose for the duration of the clincial trial | Drug | – |
Primary outcome
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)).
Time frame: 60 days
3 secondary outcomes
To evaluate the safety/tolerability of CUV1647 by measuring treatment-emergent adverse events.
Time frame: 60 days
To determine the effect of CUV1647 on melanin density at several specified body sites.
Time frame: 60 days
To evaluate a change in the MUD between Days 30 and 60.
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
Related trials for Solar Urticaria
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Active, not recruitingPhase 2
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
Hereditary Angioedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley Rhodes, M.D. principal investigator
Salford Royal Foundation Hospital (Hope Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing afamelanotide in people with Solar Urticaria, run by Clinuvel Pharmaceuticals Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.