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CompletedNCT00478751Updated Apr 30, 2024

Impact of Long Wavelength Ultraviolet (UVA) and Visible Light on Melanocompetent Skin

An observational study in Healthy, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Henry Ford Health System · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Ages
18 Years and older
Sex
All
01

Study summary

  • Determine the impact and the threshold of long wavelength UVA and visible light on immediate and delayed pigment production of melanocompetent individuals.
  • The study basically wants to understand what types of light make us tan.
Read the detailed description

  1. Background:

    • A great deal is known about the impact of UVB and short wavelength UVA on pigmentation. Most sunscreens only protect against UVB and portions of UVA. However, it is not clear if other components of the spectrum of sunlight, not currently protected by sunscreens, are capable of eliciting pigmentation. Very little is known about the impact of long wavelength UVA and visible light on the time course to pigmentation, the quality of pigmentation and durations of this change in pigment if any. This has implications on the use of sunscreens to inhibit pigment production and the treatment of conditions that are aggravated by sun exposure such as melasma.
    • The impact of visible light (400-700 nm) on melanogenesis was studied by Porges et al in 1988 . The threshold dose for IPD with visible light was between 40 and 80 J/cm2, while the threshold dose for "persistent" pigmentation was greater than or equal to 80 J/cm2 (1).

  2. Study objective:

    -To determine the impact of long wavelength UVA and visible light on immediate and delayed pigment production of melanocompetent individuals.

  3. Study design:

    • Patient to serve as their own control. Patient must be melanocompetent (skin phototypes IV to VI) with no history of vitiligo, melasma or photosensitivity. The symmetric back or forearm will be used as a control of the irradiated area. Two phototherapy delivery system will be developed for the study: 1) A targeted visible light phototherapy device, 2) A targeted long wavelength UVA device.
    • Pigmentation will be assessed by visual exam, fluorescent and reflectance spectroscopy at 6 timepoints: immediately after irradiation, 30 minutes after exposure, 1 hour after exposure, 1 day after exposure, 1 week after exposure and 2 weeks after exposure.
02

Conditions studied

  • Healthy

Keywords

  • Visible light, Long UVA,Pigmentation
  • Normal healthy volunteers with dark skin type.
03

In context

Lead sponsor

Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 24 (65%) have results posted.

Browse Henry Ford Health System studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy volunteer with Fitzpatrick Skin phototypes IV-VI.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For inclusion, the subject must:

  1. Be at least 18 years old;

  2. Be a healthy volunteer with Fitzpatrick Skin phototypes IV-VI based on the scale below:

    • Burns minimally, tans easily, and above average with each exposure
    • Rarely burns, tans easily and substantially
    • Never burns and tans profusely
  3. Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection;
  4. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
  5. Agree to follow and undergo all study-related procedures.

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded if any of the following apply:

  1. Women who are lactating, pregnant, or planning to become pregnant.
  2. Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation.
  3. Patients with a known history of photosensitivity disorders.
  4. Photosensitizing medications may be continued throughout of the study at the discretion of the investigator (appendix A).
  5. Patients with a known history of melanoma or non-melanoma skin cancers
  6. Concomitant use of tanning beds.
  7. Sun exposure of the irradiated or control areas.
  8. Any reason the investigator feels the patient should not participate in the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
22 participants (actual)
06

Study locations

1 site
  • Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
    Detroit, Michigan 48202, United States
07

References and documents

Publications

  • Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200. PubMed 3222167 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2007, a primary completion of Dec 2008 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2007
First posted
May 25, 2007
Start
May 2007
Primary completionActual
Dec 2008
CompletionActual
Jan 2009
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00478751
Lead sponsor
Henry Ford Health System
Collaborators
Johnson & Johnson
Responsible party
Iltefat Hamzavi (Dermatologist, Henry Ford Health System) — Principal investigator
First posted
May 25, 2007
Start date
May 2007
Primary completion
Dec 2008
Completion
Jan 2009
Last update
Apr 30, 2024

Study contacts

Iltefat H. Hamzavi, M.D.
principal investigator · Department of Dermatology, Henry Ford Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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