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N/A N=20 Treatment

Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles

Wrinkles

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Photographic Evaluation of Wrinkle Severity at Baseline — 5.25 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
Jul 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Photographic Evaluation of Wrinkle Severity at Baseline
5.25
PRIMARY
Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment
4.74
PRIMARY
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment
4.25
PRIMARY
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment
3.9
PRIMARY
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment
4

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

  • Is a healthy non-smoking (must have quit 6 months 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 Retin A or 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 or has an autoimmune disorder.
  • The subject has an allergy to lidocaine and epinephrine.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02091102). 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.

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