N/A
N=20
Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT02091089 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Photographic Evaluation of Wrinkle Severity at Baseline — 5.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 755nm Alexandrite laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cynosure, Inc.
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Photographic Evaluation of Wrinkle Severity at Baseline |
5.7 | — |
| PRIMARY Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up |
3 | — |
| PRIMARY Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up |
3 | — |
| PRIMARY Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up |
3 | — |
| PRIMARY Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up |
3 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using the picosecond 755nm Alexandrite laser.
Eligibility Criteria
Inclusion Criteria
- Is a healthy non-smoking (must have quit 1 year prior) male or female between 18 and 65 years old.
- Is willing to consent to participate in the study.
- 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
- 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.
- The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- The subject has active or localized systemic infections.
- 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}).
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- 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.
- The subject has used Accutane within 6 months prior to enrollment.
- The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- The subject has a history of keloids.
- The subject has evidence of compromised wound healing.
- The subject has a history of squamous cell carcinoma or melanoma.
- The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- The subject has an allergy to lidocaine and epinephrine.
Data sourced from ClinicalTrials.gov (NCT02091089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.