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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00478751
Date of registration: 24/05/2007
Primary sponsor: Henry Ford Health System
Public title: Impact of Long Wavelength Ultraviolet (UVA) and Visible Light on Melanocompetent Skin
Scientific title: Impact of Long Wavelength UVA and Visible Light on Melanocompetent Skin
Date of first enrolment: May 2007
Target sample size: 22
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00478751
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
United States
Contacts
Name:   Iltefat H. Hamzavi, M.D.
Address: 
Telephone:
Email:
Affiliation:  Department of Dermatology, Henry Ford Health System
Key inclusion & exclusion criteria

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:

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Healthy
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
IRB4502
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Johnson & Johnson
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