Study for the RevLite Laser System for Facial Solar Lentigines

The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines

Study Overview

• Status: Completed
• Conditions: Facial Solar Lentigines
• Intervention / Treatment: Device: Revlite Laser System

Detailed Description

Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Sadick Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is a healthy male or female between 18 and 60 years old.
2. Is Fitzpatrick Skin types I-III
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.

Exclusion Criteria:

1. 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. Is hypersensitive to light exposure OR takes photo sensitized medication.
3. Has active or localized systemic infections.
4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. 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. Has used Accutane within 6 months prior to enrollment.
8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. Has a history of keloids.
11. Has evidence of compromised wound healing.
12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revlite Laser System- Single Wavelength; Revlite Laser System- 1064nm wavelength will be used on half of the face.	Device: Revlite Laser System; Revlite Laser System for the Treatment of Facial Solar Lentigines
Experimental: Revlite Laser System- Dual Wavelength; Revlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face.	Device: Revlite Laser System; Revlite Laser System for the Treatment of Facial Solar Lentigines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale	Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.	1 month post last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Satisfaction Questionnaire	The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1).	1 month post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Hyperpigmentation; Pigmentation Disorders; Melanosis; Lentigo; Facies
• Other Study ID Numbers: CYN14-REV-REJUV-NS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes