- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00478751
Impact of Long Wavelength Ultraviolet (UVA) and Visible Light on Melanocompetent Skin
April 29, 2024 updated by: Iltefat Hamzavi, Henry Ford Health System
Impact of Long Wavelength UVA and Visible Light on Melanocompetent Skin
- 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.
Study Overview
Status
Completed
Conditions
Detailed Description
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).
Study objective:
-To determine the impact of long wavelength UVA and visible light on immediate and delayed pigment production of melanocompetent individuals.
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.
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healthy volunteer with Fitzpatrick Skin phototypes IV-VI.
Description
Inclusion Criteria:
For inclusion, the subject must:
- Be at least 18 years old;
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
- Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection;
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
- Agree to follow and undergo all study-related procedures.
Exclusion Criteria:
Subjects will be excluded if any of the following apply:
- Women who are lactating, pregnant, or planning to become pregnant.
- Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation.
- Patients with a known history of photosensitivity disorders.
- Photosensitizing medications may be continued throughout of the study at the discretion of the investigator (appendix A).
- Patients with a known history of melanoma or non-melanoma skin cancers
- Concomitant use of tanning beds.
- Sun exposure of the irradiated or control areas.
- Any reason the investigator feels the patient should not participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Iltefat H. Hamzavi, M.D., Department of Dermatology, Henry Ford Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
May 24, 2007
First Submitted That Met QC Criteria
May 24, 2007
First Posted (Estimated)
May 25, 2007
Study Record Updates
Last Update Posted (Actual)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 29, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- IRB4502
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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