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Sun Damaged SkinNCT05865431

Singlet Oxygen Quantification After Skin Exposure to Ultraviolet A (UVA) Light

A study testing Zinc Oxide and Avobenzone in people with Sun Damaged Skin, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sun Damaged Skin
What is being tested?
Zinc Oxide and Avobenzone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
17 Mar 2017to 2 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects aged 18 years and older

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, Davis

    Sacramento, California, 95819

Other trials in United States

About this study

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

Read the 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.

Being tested
Zinc Oxide and Avobenzone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zinc Oxide and AvobenzoneDrug

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

Study groups in NCT05865431
Study groupRoleWhat they receive
Zinc Oxide, Avobenzone, No ProductExperimentalParticipants have zinc oxide, avobenzone, and no product applied to 3 different spots on the forearm and singlet oxygen is measured after UV exposure.
Receives: Drug: Zinc Oxide and Avobenzone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 0.33 J/cm2

    Measured: 5 minutes at first visit

  2. Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 8.25 J/cm2

    Measured: 5 minutes at first visit

  3. Amount of singlet oxygen generated by the left forearm skin (2 cm^2) after exposure to UVA radiation dose of 16.5 J/cm2

    Measured: 5 minutes at first visit

Secondary outcomes (5)

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

    Measured: Within 24 hours

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

    Measured: Within 24 hours

  3. 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

    Measured: Within 24 hours

  4. 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

    Measured: Within 24 hours

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

    Measured: Within 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start17 Mar 2017
  3. Primary completion2 Feb 2018
  4. Study completion2 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05865431
Sponsor's protocol ID
1042064
Status last verified
May 2023
First submitted
7 Apr 2023
Last updated
27 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23192740

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

    PubMed 166356

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

    PubMed 12882019

  • 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.

    PubMed 24305962

  • 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.

    PubMed 23111621

  • 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.

    PubMed 12126308

Questions about this trial

What is this clinical trial studying?

A study testing Zinc Oxide and Avobenzone in people with Sun Damaged Skin, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05865431, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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