HealthyNCT00478751
Impact of Long Wavelength Ultraviolet (UVA) and Visible Light on Melanocompetent Skin
An observational study of Healthy, run by Henry Ford Health System at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2009
- Phase
- Observational
- 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
Study population: Healthy volunteer with Fitzpatrick Skin phototypes IV-VI.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
Detroit, Michigan, 48202
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Visible light, Long UVA,Pigmentation, Normal healthy volunteers with dark skin type.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat H. Hamzavi, M.D., Principal investigator, Department of Dermatology, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478751
- Sponsor's protocol ID
- IRB4502
- Status last verified
- Apr 2024
- First submitted
- 24 May 2007
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Long Wavelength UVA and Visible Light on Melanocompetent Skin
- ClinicalTrials.gov ID
- NCT00478751
- Acronym / sponsor ID
- IRB4502
- Conditions
- Healthy
- Keywords
- Visible light, Long UVA,Pigmentation, Normal healthy volunteers with dark skin type.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteer with Fitzpatrick Skin phototypes IV-VI.
Key inclusion criteria (9 listed)
- Be at least 18 years old;
- Be a healthy volunteer with Fitzpatrick Skin phototypes IV-VI based on the scale below:
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 3222167Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iltefat H. Hamzavi, M.D. principal investigator
Department of Dermatology, Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, 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 9 inclusion and 9 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 30 Apr 2024. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478751, which also lists 1 linked publication.
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 30 Apr 2024.