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Completed

NCT Number: NCT03065582

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

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.

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Key information

Conditions

Pigmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Topical Product A

Other

topical application sunscreen containing topical antioxidants and sunscreen filters

Topical Product B

Other

topical application of product A without topical antioxidants

Topical Product C

Other

Topical application of antioxidants only

Control

Other

No product applied

Primary outcomes

  1. diffuse reflectance spectroscopy

    Time frame: Baseline- immediately after irradiation to assess immediate pigment darkening

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

  2. photography

    Time frame: Baseline-immediately after irradiation to assess immediate pigment darkening

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

  3. investigator's global assessment score

    Time frame: Baseline- Immediately after irradiation to assess immediate pigment darkening

    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.

  4. Diffuse reflectance spectroscopy

    Time frame: 24 hours after irradiation to assess persistent pigment darkening

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

  5. photography

    Time frame: 24 hours after irradiation to assess persistent pigment darkening

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

  6. Investigator's global assessment score

    Time frame: 24 hours after irradiation to assess persistent pigment darkening

    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.

  7. Diffuse reflectance spectroscopy

    Time frame: 7 days after irradiation to assess delayed tanning

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

  8. Photography

    Time frame: 7 days after irradiation to assess delayed tanning

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

  9. Investigator global assessment score

    Time frame: 7 days after irradiation to assess delayed tanning

    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.

  10. Biological effects

    Time frame: 24 hours after irradiation

    biopsy with melanocyte and melanin stains to assess pigmentation

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Allergan

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 28, 2017
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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