Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation

Not Applicable

Completed

• Conditions: Facial Rejuvenation
• Interventions: Device: 755nm Laser with Cap Array

• Registration Number: NCT02107157
• Lead Sponsor: Cynosure, Inc.

Brief Summary

The purpose of this study is to assess treatment of facial rejuvenation using the standard hand piece and a Lens Array for the 755nm Alexandrite laser.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2020-10-20
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Results First Posted: 2021-01-20
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Is a healthy 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 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.
14. The subject has an allergy to lidocaine and epinephrine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
755nm Alexandrite laser with cap array	755nm Laser with Cap Array	-

Primary Outcome Measures

Name	Time	Method
Photodamage Score Change	Baseline and 3 months post last treatment	The photodamage is assessed by examining fine wrinkles, mottled hyperpigmentation, and overall integrated assessment of photodamage. These 3 categories are broken down into their own scales of 0 to 4 based on severity. 0 indicates none, 1 indicates minimal, 2 indicates mild, 3 indicates moderate, and 4 indicates severe. The total points from all 3 categories added up will range from 0 to 12, where 12 is the most photodamage possible. A decrease in score indicates less photodamage.
Changes in Facial Scarring Score	Baseline and 3 months post last treatment	Physicians will examine the subjects' facial scarring using the Physician Global Scarring Grading (PGSG) scale. This scale counts and types scars by tallying up of the number and severity of the scars according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Number of Participants With Signs of New Collagen Generations	3 months post last treatment	Subjects will have one 3mm punch biopsy obtained pretreatment from an inconspicuous area and subsequent biopsies at one or any of the following visits after treatment. Pathologies will be provided by pathologists who are able to determine any developments of dermal mucus, dermal elastic fibers, or changes in collagen III. An increase in any of these categories corresponds with skin rejuvenation.

Trial Locations

Locations (1)

Dermatology and Laser Surgery; 🇺🇸 Sacramento, California, United States