Status:
COMPLETED
Skin Safety Profile of Different Exposure to the Light Emitting Diode (LED) in Healthy Subjects
Lead Sponsor:
L'Oreal
Conditions:
Radiation Tolerance
Skin Aging
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Photomodulation is a process which manipulates or regulates cell activity using light sources without thermal effect. Different studies have investigated the use of non-thermal low dose light emitting...
Detailed Description
The purpose of this study is to evaluate different treatment regimens in order to be able to develop new indications or to optimize the result already obtained in the treatment of wrinkles around the ...
Eligibility Criteria
Inclusion
- Healthy subjects (male and female) at least 18 years old with skin types range from Fitzpatrick type I-VI (Appendix 1),
- Subjects must read, understand and sign the informed consent,
- Subjects must be willing and able to comply with follow up requirements,
- To be willing to report any medications taken during the study and refrain from taking any medication during the study that might produce photoreactions.
Exclusion
- Subjects must not have active or localized or systemic infection,
- Subjects must not be immunocompromised,
- Subjects must be negative for HIV and hepatitis B and C serology,
- Subjects must not have history of light activated seizure or migraine headache disorder,
- Individuals taking medication who have been advised by a physician or pharmacist to avoid sunlight and subjects having vitiligo
- Subjects must not have mental illness such as schizophrenia or severe depression,
- Subjects must not have photosensitivity, photoallergy or photodermatitis,
- Subjects must not be pregnant or breast feeding. Subjects must discuss concerns about birth control with the study physician. Subjects who become pregnant during the study must inform the investigator immediately,
- Subject must not have a skin condition that the examining Investigator deems inappropriate for participation,
- Subject must not take part or intend to take part in another study liable to interfere with this study whatever the region of the body considered for 30 days prior to the study start and 30 days following completion of the study,
- Subjects must not have had GentleWaves treatment, other light treatments (including tanning beds), collagen or other facial tissue augmentation, Botox®, chemical peels, non-ablative (non invasive laser) therapies, dermabrasion, topical antioxidant or other resurfacing procedures at any time during the study,
- Subject must not refuse to sign the informed consent document and/or refuse to comply with all study requirements,
- Subjects must not have any previous history of keloïd scarring.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00818311
Start Date
June 1 2008
End Date
December 1 2008
Last Update
January 7 2009
Active Locations (1)
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1
Thomas Stephens and Associates, Inc
Carrollton, Texas, United States, 75006