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PigmentationNCT03065582

The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects

A study testing Topical Product A, Topical Product B and Topical Product C in people with Pigmentation, run by Henry Ford Health System 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

Visible light is known to induce pigmentation in darker skin types. The investigators aim to study the effects of visible light on the skin after topical application of sunscreen plus antioxidant. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pigmentation
What is being tested?
Topical Product A, Topical Product B and Topical Product C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
13 Mar 2018to 22 Apr 2019
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

  • Patient age 18 and older
  • Patients Fitzpatrick skin phototype IV-VI
  • Patient able to understand requirements of the study and risks involved
  • Patient able to sign a consent form

Who cannot join

  • A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
  • A known history of photodermatoses
  • A known history of melanoma or non-melanoma skin cancers
  • Those planning on going to the tanning parlors
  • Using any of the photosensitizing medication within the visible light range or additional medications at the discretion of the investigator (examples include (but not limited to) thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole)
  • A woman who is lactating, pregnant, or planning to become pregnant
  • Patient planning on exposing the irradiated or control areas to the sun
  • known allergy to anesthetics (lidocaine or epinephrine)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Henry Ford Hospital

    Detroit, Michigan, 48202

Other trials in United States

About this study

Visible light is known to induce pigmentation in darker skin types. The investigators aim to study the effects of visible light on the skin after topical application of sunscreen plus antioxidant.

Conditions
Pigmentation
Being tested
Topical Product A, Topical Product B, Topical Product C, Control

What participants receive

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

  • Topical Product AOther

    topical application sunscreen containing topical antioxidants and sunscreen filters

  • Topical Product BOther

    topical application of product A without topical antioxidants

  • Topical Product COther

    Topical application of antioxidants only

  • ControlOther

    No product applied

Study groups in NCT03065582
Study groupRoleWhat they receive
Sunscreen applicationExperimentalAll subjects will undergo topical application of 3 products and an additional site will serve as a control
Receives: Other: Topical Product A; Other: Topical Product B; Other: Topical Product C; Other: Control

What is being measured

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

  1. diffuse reflectance spectroscopy

    Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin

    Measured: Baseline- immediately after irradiation to assess immediate pigment darkening

  2. photography

    Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin.

    Measured: Baseline-immediately after irradiation to assess immediate pigment darkening

  3. investigator's global assessment score

    The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation.

    Measured: Baseline- Immediately after irradiation to assess immediate pigment darkening

  4. Diffuse reflectance spectroscopy

    Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin

    Measured: 24 hours after irradiation to assess persistent pigment darkening

  5. photography

    Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin.

    Measured: 24 hours after irradiation to assess persistent pigment darkening

  6. Investigator's global assessment score

    The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation.

    Measured: 24 hours after irradiation to assess persistent pigment darkening

  7. Diffuse reflectance spectroscopy

    Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin

    Measured: 7 days after irradiation to assess delayed tanning

  8. Photography

    Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin.

    Measured: 7 days after irradiation to assess delayed tanning

  9. Investigator global assessment score

    The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation.

    Measured: 7 days after irradiation to assess delayed tanning

  10. Biological effects

    biopsy with melanocyte and melanin stains to assess pigmentation

    Measured: 24 hours after irradiation

Timeline

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

  1. First posted28 Feb 2017
  2. Study start13 Mar 2018
  3. Primary completion15 Sep 2018
  4. Study completion22 Apr 2019

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03065582
Sponsor's protocol ID
IRB # 9695
Status last verified
Feb 2022
First submitted
30 Jan 2017
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be available to other researchers.

Publications

  • Mahmoud BH, Hexsel CL, Hamzavi IH, Lim HW. Effects of visible light on the skin. Photochem Photobiol. 2008 Mar-Apr;84(2):450-62. doi: 10.1111/j.1751-1097.2007.00286.x. Epub 2008 Jan 29.

    PubMed 18248499

  • Kollias N, Baqer A. An experimental study of the changes in pigmentation in human skin in vivo with visible and near infrared light. Photochem Photobiol. 1984 May;39(5):651-9. doi: 10.1111/j.1751-1097.1984.tb03905.x. No abstract available.

    PubMed 6739557

  • Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.

    PubMed 3222167

  • Mahmoud BH, Ruvolo E, Hexsel CL, Liu Y, Owen MR, Kollias N, Lim HW, Hamzavi IH. Impact of long-wavelength UVA and visible light on melanocompetent skin. J Invest Dermatol. 2010 Aug;130(8):2092-7. doi: 10.1038/jid.2010.95. Epub 2010 Apr 22.

    PubMed 20410914

  • Duteil L, Cardot-Leccia N, Queille-Roussel C, Maubert Y, Harmelin Y, Boukari F, Ambrosetti D, Lacour JP, Passeron T. Differences in visible light-induced pigmentation according to wavelengths: a clinical and histological study in comparison with UVB exposure. Pigment Cell Melanoma Res. 2014 Sep;27(5):822-6. doi: 10.1111/pcmr.12273. Epub 2014 Jul 25.

    PubMed 24888214

  • Yakes FM, Van Houten B. Mitochondrial DNA damage is more extensive and persists longer than nuclear DNA damage in human cells following oxidative stress. Proc Natl Acad Sci U S A. 1997 Jan 21;94(2):514-9. doi: 10.1073/pnas.94.2.514.

    PubMed 9012815

  • Boukari F, Jourdan E, Fontas E, Montaudie H, Castela E, Lacour JP, Passeron T. Prevention of melasma relapses with sunscreen combining protection against UV and short wavelengths of visible light: a prospective randomized comparative trial. J Am Acad Dermatol. 2015 Jan;72(1):189-90.e1. doi: 10.1016/j.jaad.2014.08.023. Epub 2014 Oct 22. No abstract available.

    PubMed 25443629

  • Wang SQ, Osterwalder U, Jung K. Ex vivo evaluation of radical sun protection factor in popular sunscreens with antioxidants. J Am Acad Dermatol. 2011 Sep;65(3):525-530. doi: 10.1016/j.jaad.2010.07.009. Epub 2011 May 31.

    PubMed 21624700

  • Kunisada M, Sakumi K, Tominaga Y, Budiyanto A, Ueda M, Ichihashi M, Nakabeppu Y, Nishigori C. 8-Oxoguanine formation induced by chronic UVB exposure makes Ogg1 knockout mice susceptible to skin carcinogenesis. Cancer Res. 2005 Jul 15;65(14):6006-10. doi: 10.1158/0008-5472.CAN-05-0724.

    PubMed 16024598

  • Herrling T, Jung K, Fuchs J. Measurements of UV-generated free radicals/reactive oxygen species (ROS) in skin. Spectrochim Acta A Mol Biomol Spectrosc. 2006 Mar 13;63(4):840-5. doi: 10.1016/j.saa.2005.10.013.

    PubMed 16543118

Questions about this trial

What is this clinical trial studying?

A study testing Topical Product A, Topical Product B and Topical Product C in people with Pigmentation, run by Henry Ford Health System 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 4 inclusion and 8 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 2 Mar 2022. 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?

diffuse reflectance spectroscopy (time frame: Baseline- immediately after irradiation to assess immediate pigment darkening). The study lists 10 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 NCT03065582, which also lists 10 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 2 Mar 2022.

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