Characterisation of the Time-course Response of UV-induced Erythema (CHERY)
Primary Purpose
Erythema
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MED Test
Wearing device
Sponsored by
About this trial
This is an interventional basic science trial for Erythema focused on measuring erythema, photobiology, photomedicine, phototherapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Morning exposure in week 1
Afternoon exposure in week 1
Arm Description
Participants will have their first week of testing starting in the morning
Participants will have their first week of testing starting in the afternoon
Outcomes
Primary Outcome Measures
Measure 2x 48 hour erythema time courses on each participant
Secondary Outcome Measures
Measure 2 MEDs (minimal erythemal doses) in each participant, at morning and afternoon exposures each
Full Information
NCT ID
NCT04290273
First Posted
February 26, 2020
Last Updated
May 10, 2023
Sponsor
University of Dundee
Collaborators
NHS Tayside
1. Study Identification
Unique Protocol Identification Number
NCT04290273
Brief Title
Characterisation of the Time-course Response of UV-induced Erythema
Acronym
CHERY
Official Title
Characterisation of the Time-course Response of UV-induced Erythema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
Collaborators
NHS Tayside
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema
Keywords
erythema, photobiology, photomedicine, phototherapy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morning exposure in week 1
Arm Type
Experimental
Arm Description
Participants will have their first week of testing starting in the morning
Arm Title
Afternoon exposure in week 1
Arm Type
Experimental
Arm Description
Participants will have their first week of testing starting in the afternoon
Intervention Type
Diagnostic Test
Intervention Name(s)
MED Test
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Wearing device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure 2x 48 hour erythema time courses on each participant
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Measure 2 MEDs (minimal erythemal doses) in each participant, at morning and afternoon exposures each
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
15004824
Citation
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.
Results Reference
background
PubMed Identifier
12833009
Citation
Man 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.
Results Reference
background
PubMed Identifier
12929749
Citation
Man 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.
Results Reference
background
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Characterisation of the Time-course Response of UV-induced Erythema
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