ErythemaCHERYNCT04290273
Characterisation of the Time-course Response of UV-induced Erythema
A study testing MED Test and Wearing device in people with Erythema, run by University of Dundee.
Trial summary
Erythema is a physiological response to an insult on the skin. One such insult is ultraviolet (UV) radiation, with the resultant erythema also known as sunburn. It is a reddening of the skin as a result of increased blood flow to the area. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erythema
- What is being tested?
- MED Test and Wearing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Nov 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers. No clinically significant abnormality identified by evaluation of medical history, in particular no evidence of photosensitivity
- Adult males and females, >18 years only
- Capable of giving informed consent
- Able to understand and adhere to protocol requirements
- Skin phototype I - III
Who cannot join
- Contact allergy to adhesives tapes
- Abnormal rash/pigmentation on thighs
- Unable to give informed consent
- Known to have a light sensitive disorder
- Pregnant, breastfeeding or planning to conceive
- Skin phototype IV - VI
- Lack of space on thighs for test procedures
About this study
Erythema is a physiological response to an insult on the skin. One such insult is ultraviolet (UV) radiation, with the resultant erythema also known as sunburn. It is a reddening of the skin as a result of increased blood flow to the area. By controlled exposure to UV radiation, a minimal erythema dose (MED) indicative of threshold erythemal sensitivity to the exposure waveband may be determined - this is determined visually by a trained clinician as the dose of light required to cause a just perceptible reddening of the skin. The MED of a specific patient on a specific skin site is an important measurement - it can allow for determination of initial dose in UV phototherapy, provides an indication of background levels of photosensitivity in diagnostic phototesting and may be influenced by exogenous factors, such as photoactive drugs.
The erythema response has been measured previously using non-invasive hand-held devices for a variety of UV exposures, including narrow-band (NB-)UVB, UVA and UVA1. Typically, the participant will be exposed in the morning (t = 0h) and have a reading taken immediately after. These readings are assessed visually by a trained clinician, or occasionally reflectance devices are used quantify erythema. The participant will then return at the end of the working day (t ~ 8h) for another reading, and again the next morning for another reading (t ~ 24h). This results in large gaps in the knowledge of erythemal response over time.
Read more
In this study the investigators aim to characterise the erythema response as a result of UV insult using a wearable erythema device to take continual measurements. This would allow us to more accurately determine the time point of peak erythema, which would inform and potentially change our current practice in reading MEDs. The investigators have previous experience of studies using reflectance devices to measure erythema time course at fixed intervals, however there are still gaps in the knowledge of the time course response of erythema.
There is no expected health benefit to participants in this study, however they may gain a better understanding of their responses to ultraviolet light MED testing. Controlled UV exposures are commonplace in our practice in the Photobiology Unit and it is not foreseen that there are any risks to participation in the study.
The primary objective in this study is to determine when the peak erythema index occurs in a healthy volunteer group. Success of this outcome will help fill in these gaps in the knowledge about the time course of erythema. The secondary objective is to determine if there is any difference in MED and/or peak erythema if the UV exposure is delivered in the morning vs. the afternoon. The outcomes of the research will be 20 sets (2 per participant) of continuous 48-hour erythema measurements.
- Conditions
- Erythema
- Being tested
- MED Test, Wearing device
- Keywords
- erythema, photobiology, photomedicine, phototherapy
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED TestDiagnostic test
Participant is irradiated with several doses of UV light on small areas of the outer thigh. 24 hours later this area is visually inspected for erythema, and the minimal erythemal dose (MED) is determined.
Wearing deviceDevice
Participants wear a portable erythema measurement device for 48 hours. The device shines light on the skin at frequent intervals and measures skin 'redness'. The device is removed by a technician after the 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Morning exposure in week 1 | Experimental | Participants will have their first week of testing starting in the morning Receives: Diagnostic Test: MED Test; Device: Wearing device |
| Afternoon exposure in week 1 | Experimental | Participants will have their first week of testing starting in the afternoon Receives: Diagnostic Test: MED Test; Device: Wearing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure 2x 48 hour erythema time courses on each participant
Measured: 6 months
Secondary outcomes (1)
Measure 2 MEDs (minimal erythemal doses) in each participant, at morning and afternoon exposures each
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study startSep 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: workforce issues which made practical delivery of the study impossible to do atthe current time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ErythemaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside
- Responsible party
- Principal investigator, Sally Ibbotson, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290273
- Sponsor's protocol ID
- 2-004-20
- Acronym
- CHERY
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dolotov LE, Sinichkin YP, Tuchin VV, Utz SR, Altshuler GB, Yaroslavsky IV. Design and evaluation of a novel portable erythema-melanin-meter. Lasers Surg Med. 2004;34(2):127-35. doi: 10.1002/lsm.10233.
PubMed 15004824Man I, McKinlay J, Dawe RS, Ferguson J, Ibbotson SH. An intraindividual comparative study of psoralen-UVA erythema induced by bath 8-methoxypsoralen and 4, 5', 8-trimethylpsoralen. J Am Acad Dermatol. 2003 Jul;49(1):59-64. doi: 10.1067/mjd.2003.419.
PubMed 12833009Man I, Dawe RS, Ferguson J, Ibbotson SH. An intraindividual study of the characteristics of erythema induced by bath and oral methoxsalen photochemotherapy and narrowband ultraviolet B. Photochem Photobiol. 2003 Jul;78(1):55-60. doi: 10.1562/0031-8655(2003)0782.0.co;2.
PubMed 12929749
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of the Time-course Response of UV-induced Erythema
- ClinicalTrials.gov ID
- NCT04290273
- Acronym / sponsor ID
- CHERY / 2-004-20
- Conditions
- Erythema
- Keywords
- erythema, photobiology, photomedicine, phototherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: workforce issues which made practical delivery of the study impossible to do atthe current time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Tayside
- Study start
- Sep 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 Feb 2020 (actual)
- 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.
Erythema is a physiological response to an insult on the skin. One such insult is ultraviolet (UV) radiation, with the resultant erythema also known as sunburn. It is a reddening of the skin as a result of increased blood flow to the area. By controlled exposure to UV radiation, a minimal erythema dose (MED) indicative of threshold erythemal sensitivity to the exposure waveband may be determined - this is determined visually by a trained clinician as the dose of light required to cause a just perceptible reddening of the skin. The MED of a specific patient on a specific skin site is an important measurement - it can allow for determination of initial dose in UV phototherapy, provides an indication of background levels of photosensitivity in diagnostic phototesting and may be influenced by exogenous factors, such as photoactive drugs.
The erythema response has been measured previously using non-invasive hand-held devices for a variety of UV exposures, including narrow-band (NB-)UVB, UVA and UVA1. Typically, the participant will be exposed in the morning (t = 0h) and have a reading taken immediately after. These readings are assessed visually by a trained clinician, or occasionally reflectance devices are used quantify erythema. The participant will then return at the end of the working day (t ~ 8h) for another reading, and again the next morning for another reading (t ~ 24h). This results in large gaps in the knowledge of erythemal response over time.
In this study the investigators aim to characterise the erythema response as a result of UV insult using a wearable erythema device to take continual measurements. This would allow us to more accurately determine the time point of peak erythema, which would inform and potentially change our current practice in reading MEDs. The investigators have previous experience of studies using reflectance devices to measure erythema time course at fixed intervals, however there are still gaps in the knowledge of the time course response of erythema.
There is no expected health benefit to participants in this study, however they may gain a better understanding of their responses to ultraviolet light MED testing. Controlled UV exposures are commonplace in our practice in the Photobiology Unit and it is not foreseen that there are any risks to participation in the study.
The primary objective in this study is to determine when the peak erythema index occurs in a healthy volunteer group. Success of this outcome will help fill in these gaps in the knowledge about the time course of erythema. The secondary objective is to determine if there is any difference in MED and/or peak erythema if the UV exposure is delivered in the morning vs. the afternoon. The outcomes of the research will be 20 sets (2 per participant) of continuous 48-hour erythema measurements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning exposure in week 1 | Experimental | Diagnostic Test: MED Test, Device: Wearing deviceParticipants will have their first week of testing starting in the morning |
| Afternoon exposure in week 1 | Experimental | Diagnostic Test: MED Test, Device: Wearing deviceParticipants will have their first week of testing starting in the afternoon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteers. No clinically significant abnormality identified by evaluation of medical history, in particular no evidence of photosensitivity
- Adult males and females, >18 years only
- Capable of giving informed consent
- Able to understand and adhere to protocol requirements
- Skin phototype I - III
Key exclusion criteria (7 listed)
- Contact allergy to adhesives tapes
- Abnormal rash/pigmentation on thighs
- Unable to give informed consent
- Known to have a light sensitive disorder
- Pregnant, breastfeeding or planning to conceive
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 |
|---|---|---|
| MED TestParticipant is irradiated with several doses of UV light on small areas of the outer thigh. 24 hours later this area is visually inspected for erythema, and the minimal erythemal dose (MED) is determined. | Diagnostic test | Afternoon exposure in week 1, Morning exposure in week 1 |
| Wearing deviceParticipants wear a portable erythema measurement device for 48 hours. The device shines light on the skin at frequent intervals and measures skin 'redness'. The device is removed by a technician after the 48 hours. | Device | Afternoon exposure in week 1, Morning exposure in week 1 |
Primary outcome
Measure 2x 48 hour erythema time courses on each participant
Time frame: 6 months
1 secondary outcome
Measure 2 MEDs (minimal erythemal doses) in each participant, at morning and afternoon exposures each
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 15004824Dolotov LE, Sinichkin YP, Tuchin VV, Utz SR, Altshuler GB, Yaroslavsky IV. Design and evaluation of a novel portable erythema-melanin-meter. Lasers Surg Med. 2004;34(2):127-35. doi: 10.1002/lsm.10233.
- Background: PubMed 12833009Man I, McKinlay J, Dawe RS, Ferguson J, Ibbotson SH. An intraindividual comparative study of psoralen-UVA erythema induced by bath 8-methoxypsoralen and 4, 5', 8-trimethylpsoralen. J Am Acad Dermatol. 2003 Jul;49(1):59-64. doi: 10.1067/mjd.2003.419.
- Background: PubMed 12929749Man I, Dawe RS, Ferguson J, Ibbotson SH. An intraindividual study of the characteristics of erythema induced by bath and oral methoxsalen photochemotherapy and narrowband ultraviolet B. Photochem Photobiol. 2003 Jul;78(1):55-60. doi: 10.1562/0031-8655(2003)0782.0.co;2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MED Test and Wearing device in people with Erythema, run by University of Dundee.
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 7 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: withdrawn, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measure 2x 48 hour erythema time courses on each participant (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290273, which also lists 3 linked publications.
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 Mar 2024.