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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
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Erythema focused on measuring erythema, photobiology, photomedicine, phototherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 26, 2020
    Last Updated
    May 10, 2023
    Sponsor
    University of Dundee
    Collaborators
    NHS Tayside
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    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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