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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05865431
Other study ID # 1042064-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2017
Est. completion date February 2, 2018

Study information

Verified date May 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is quantification of singlet oxygen species in the skin after exposure to Ultraviolet A (UVA) light


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date February 2, 2018
Est. primary completion date February 2, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Zinc Oxide and Avobenzone
Zinc Oxide is applied to one area of the forearm, Avobenzone is applied to another area of the forearm.

Locations

Country Name City State
United States University of California, Davis Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Langstaff SR. Nursing care study. Rheumatoid arthritis treated with penicillamine. Nurs Times. 1975 Jun 12;71(24):918-9. No abstract available. — View Citation

Menter JM, Hatch KL. Clothing as solar radiation protection. Curr Probl Dermatol. 2003;31:50-63. doi: 10.1159/000072237. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 0.33 J/cm2 5 minutes at first visit
Primary Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 8.25 J/cm2 5 minutes at first visit
Primary Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 16.5 J/cm2 5 minutes at first visit
Secondary Difference in singlet oxygen (as measured by singlet oxygen molecule numbers) generated between individuals of different skin Fitzpatrick skin types Within 24 hours
Secondary Difference in singlet oxygen (as measured by thymidine dimer %) generated between individuals of different skin Fitzpatrick skin types Within 24 hours
Secondary 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 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
Secondary 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 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 Within 24 hours
Secondary Change in appearance of skin pigmentation as measured by colorimetry after UVA exposure Within 24 hours
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