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

NCT02091089 | Completed Results

• 1 other identifier: CYN13-PICO-LENS-RW
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using the picosecond 755nm Alexandrite laser.

Conditions

Wrinkles

Outcome Measures

Primary Outcomes (5)

• Photographic Evaluation of Wrinkle Severity at Baseline

  Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

  Baseline

• Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up

  Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

  1 Month Follow Up Post Last Treatment

• Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up

  Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

  3 Month Follow Up Post Last Treatment

• Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up

  Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

  4 months post last treatment

• Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up

  Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).

  6 months post last treatment

Study Arms (1)

755nm Alexandrite laser

EXPERIMENTAL

755nm Alexandrite laser for the treatment of wrinkles

Device: 755nm Alexandrite laser

Interventions

755nm Alexandrite laser DEVICE

755nm Alexandrite laser for the treatment of wrinkles

755nm Alexandrite laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Maryland Laser, Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

800-886-2966

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 19, 2014
• Study Start: August 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 27, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11

Locations

US (1)