Clinical trial NCT02091102: Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
Official title: Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using a 755nm Alexandrite Laser.


Eligibility criteria: 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.

Primary outcomes:
measure: Photographic Evaluation of Wrinkle Severity at Baseline
timeFrame: Baseline
measure: Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment
timeFrame: 1 Month Follow Up Post Last Treatment
measure: Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment
timeFrame: 3 Month Follow Up Post Last Treatment
measure: Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment
timeFrame: 4 Month Follow Up Post Last Treatment
measure: Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment
timeFrame: 6 Month Follow Up Post Last Treatment
Secondary outcomes:
Other outcomes:
measure: Satisfaction Questionnaire
timeFrame: up to 6 months post last treatment
Locations:
city: Virginia Beach
country: United States
facility: McDaniel Institute of Anti Aging Research
state: Virginia
Study officials:
References: