Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
Status: | Completed |
---|---|
Conditions: | Cosmetic |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | August 2013 |
End Date: | July 2014 |
Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
The purpose of this study is to evaluate the efficacy and safety of the treatment of
wrinkles using a 755nm Alexandrite Laser.
wrinkles using a 755nm Alexandrite Laser.
Inclusion Criteria:
1. Is a healthy non-smoking (must have quit 6 months prior) male or female between 18
and 65 years old.
2. Is willing to consent to participate in the study.
3. Is willing to comply with all requirements of the study including biopsies, being
photographed, following post treatment care and attending all treatment and follow up
visits.
Exclusion Criteria:
1. The subject 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. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections.
4. The subject has a coagulation disorder or is currently using anti-coagulation
medication (including but not limited to heavy aspirin therapy {greater than 81 mg
per day}).
5. The subject has any condition which, in the investigator's opinion, would make it
unsafe for the subject to participate in this research study.
6. The subject 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. The subject has used Retin A or Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive
sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium
thiomalate).
10. The subject has a history of keloids.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including
HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune
disorder.
14. The subject has an allergy to lidocaine and epinephrine.
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