- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05865431
Singlet Oxygen Quantification After Skin Exposure to Ultraviolet A (UVA) Light
May 9, 2023 updated by: University of California, Davis
The objective of this study is quantification of singlet oxygen species in the skin after exposure to Ultraviolet A (UVA) light
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ultraviolet (UV) radiation can lead to skin damage and cancer.
Ultraviolet A (UVA) irradiation is 10 to 100 times more abundant in natural sunlight than ultraviolet B (UVB), thus human skin is exposed to more UVA irradiation daily.UVA irradiation is not completely filtered by clothing and it penetrates deeper into the dermis than UVB, potentially causing more damage.
It is believed that skin cancer, photo aging, and skin immunomodulation are mediated by the reactive oxygen species (ROS) that are generated in response to UV radiation.
Singlet oxygen (1O2) is one type of ROS.
The aim of this study is to quantify the level of singlet oxygen generated in the skin after exposure to UVA radiation.
Previous studies have used low dose ultraviolet A1(UVA1) irradiation of 20 J/cm2, which mimics exposure to strong sunlight of approximately two hours.
This study will use UVA doses equivalent to or less than what humans are exposed to in daily life.
Additionally, the aim is to quantify singlet oxygen produced in individuals of various skin types before and after application of sunscreens containing zinc oxide and avobenzone (sun protection factor 30).
To our knowledge, there is no method for quantifying singlet oxygen in human skin after exposure to UVA light.
This is a novel method that may help the investigators understand further the protective effects of various skin types, as well as sunscreens.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Sacramento, California, United States, 95819
- University of California, Davis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Subjects aged 18 years and older
Exclusion Criteria:
- Those who are currently smoking or have smoked within the past 3 years.
- Aspirin use
- Multivitamins and supplements that contain vitamin E
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zinc Oxide, Avobenzone, No Product
Participants have zinc oxide, avobenzone, and no product applied to 3 different spots on the forearm and singlet oxygen is measured after UV exposure.
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Zinc Oxide is applied to one area of the forearm, Avobenzone is applied to another area of the forearm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 0.33 J/cm2
Time Frame: 5 minutes at first visit
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5 minutes at first visit
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Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 8.25 J/cm2
Time Frame: 5 minutes at first visit
|
5 minutes at first visit
|
Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 16.5 J/cm2
Time Frame: 5 minutes at first visit
|
5 minutes at first visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in singlet oxygen (as measured by singlet oxygen molecule numbers) generated between individuals of different skin Fitzpatrick skin types
Time Frame: Within 24 hours
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Within 24 hours
|
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Difference in singlet oxygen (as measured by thymidine dimer %) generated between individuals of different skin Fitzpatrick skin types
Time Frame: Within 24 hours
|
Within 24 hours
|
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Difference in singlet oxygen generation with avobenzone and zinc oxide sunscreens (sun protection factor 30 and 2mg/cm^2 applied for each) vs control (no sunscreen) after exposure to 444.1millijoules (mJ) /cm2 UVA exposure
Time Frame: Within 24 hours
|
Difference in singlet oxygen generation (as measured by thymidine dimer %) with two different sunscreens (zinc oxide and avobenzone, each sun protection factor 30 and 2mg/cm^2 applied) vs control (no sunscreen) after exposure to 444.1mJ/cm2 UVA exposure
|
Within 24 hours
|
Difference in singlet oxygen generation with avobenzone and zinc oxide sunscreens (sun protection factor 30 and 2mg/cm^2 applied for each) vs control (no sunscreen) after exposure to 444.1millijoules (mJ) /cm2 UVA exposure
Time Frame: Within 24 hours
|
Difference in singlet oxygen generation (as measured by singlet oxygen molecule numbers) with two different sunscreens (zinc oxide and avobenzone, each sun protection factor 30 and 2mg/cm^2 applied) vs control (no sunscreen) after exposure to 444.1mJ/cm2 UVA exposure
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Within 24 hours
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Change in appearance of skin pigmentation as measured by colorimetry after UVA exposure
Time Frame: Within 24 hours
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Within 24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sklar LR, Almutawa F, Lim HW, Hamzavi I. Effects of ultraviolet radiation, visible light, and infrared radiation on erythema and pigmentation: a review. Photochem Photobiol Sci. 2013 Jan;12(1):54-64. doi: 10.1039/c2pp25152c.
- Tewari A, Grage MM, Harrison GI, Sarkany R, Young AR. UVA1 is skin deep: molecular and clinical implications. Photochem Photobiol Sci. 2013 Jan;12(1):95-103. doi: 10.1039/c2pp25323b.
- Langstaff SR. Nursing care study. Rheumatoid arthritis treated with penicillamine. Nurs Times. 1975 Jun 12;71(24):918-9. No abstract available.
- Menter JM, Hatch KL. Clothing as solar radiation protection. Curr Probl Dermatol. 2003;31:50-63. doi: 10.1159/000072237.
- Wang F, Smith NR, Tran BA, Kang S, Voorhees JJ, Fisher GJ. Dermal damage promoted by repeated low-level UV-A1 exposure despite tanning response in human skin. JAMA Dermatol. 2014 Apr;150(4):401-6. doi: 10.1001/jamadermatol.2013.8417.
- Hanson KM, Clegg RM. Observation and quantification of ultraviolet-induced reactive oxygen species in ex vivo human skin. Photochem Photobiol. 2002 Jul;76(1):57-63. doi: 10.1562/0031-8655(2002)0762.0.co;2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2017
Primary Completion (Actual)
February 2, 2018
Study Completion (Actual)
February 2, 2018
Study Registration Dates
First Submitted
April 7, 2023
First Submitted That Met QC Criteria
May 9, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Actual)
May 18, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1042064-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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