Study for the RevLite Laser System for Facial Solar Lentigines
Status: | Completed |
---|---|
Conditions: | Other Indications, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery, Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 4/21/2016 |
Start Date: | March 2014 |
End Date: | February 2015 |
The purpose of this study is to evaluate the effects of the Revlite Laser System for
treatment of facial solar lentigines
treatment of facial solar lentigines
Inclusion Criteria:
1. Is a healthy male or female between 18 and 60 years old.
2. Is Fitzpatrick Skin types I-III
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed,
following post treatment care and attending all treatment and follow up visits.
5. Has clinically determined mild to severe facial mottled pigmentation (solar
lentigines) on the face.
Exclusion Criteria:
1. Is female and pregnant, has been pregnant within the last 3 months, is currently
breast feeding or planning a pregnancy during the study period.
2. Is hypersensitive to light exposure OR takes photo sensitized medication.
3. Has active or localized systemic infections.
4. Has a coagulation disorder or is currently using anti-coagulation medication
(including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
5. Has any condition which, in the investigator's opinion, would make it unsafe for the
subject to participate in this research study.
6. Is currently enrolled in an investigational drug or device trial, or has received an
investigational drug or been treated with an investigational device within 3 months
prior to entering this study.
7. Has used Accutane within 6 months prior to enrollment.
8. Has the need to be exposed to artificial tanning devices or excessive sunlight during
the trial.
9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. Has a history of keloids.
11. Has evidence of compromised wound healing.
12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
13. Has a history of immunosuppression/immune deficiency disorders (including HIV
infection or AIDS) or use of immunosuppressive medications or has an autoimmune
disorder.
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