NCT05865431

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
Last Updated

April 27, 2025

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

April 7, 2023

Last Update Submit

April 24, 2025

Conditions

Sun Damaged Skin

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Difference in singlet oxygen (as measured by singlet oxygen molecule numbers) generated between individuals of different skin Fitzpatrick skin types

    Within 24 hours

  • Difference in singlet oxygen (as measured by thymidine dimer %) generated between individuals of different skin Fitzpatrick skin types

    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

    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

    Within 24 hours

  • Change in appearance of skin pigmentation as measured by colorimetry after UVA exposure

    Within 24 hours

Study Arms (1)

Zinc Oxide, Avobenzone, No Product

EXPERIMENTAL

Participants have zinc oxide, avobenzone, and no product applied to 3 different spots on the forearm and singlet oxygen is measured after UV exposure.

Drug: Zinc Oxide and Avobenzone

Interventions

Zinc Oxide and AvobenzoneDRUG

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

Zinc Oxide, Avobenzone, No Product

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged 18 years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Sacramento, California, 95819, United States

Location

Related Publications (6)

  • 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.

    PMID: 23192740BACKGROUND

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

    PMID: 166356BACKGROUND

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

    PMID: 12882019BACKGROUND

  • 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.

    PMID: 24305962BACKGROUND

  • 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.

    PMID: 23111621BACKGROUND

  • 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.

    PMID: 12126308BACKGROUND

MeSH Terms

Interventions

Zinc Oxideavobenzone

Intervention Hierarchy (Ancestors)

OxidesOxygen CompoundsInorganic ChemicalsZinc Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2023

First Posted

May 18, 2023

Study Start

March 17, 2017

Primary Completion

February 2, 2018

Study Completion

February 2, 2018

Last Updated

April 27, 2025

Record last verified: 2023-05

Locations

US(1)