Study for the RevLite Laser System for Facial Solar Lentigines

Cynosure

Status: Completed

Conditions: Facial Solar Lentigines

Treatments: Device: Revlite Laser System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02110108

CYN14-REV-REJUV-NS

Details and patient eligibility

About

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

Full description

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Revlite Laser System- Single Wavelength

Experimental group

Description:

Revlite Laser System- 1064nm wavelength will be used on half of the face.

Treatment:

Device: Revlite Laser System

Revlite Laser System- Dual Wavelength

Experimental group

Description:

Revlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face.

Treatment:

Device: Revlite Laser System