Clinical trial NCT02110108: Study for the RevLite Laser System for Facial Solar Lentigines
Official title: Study for the RevLite Laser System for Facial Solar Lentigines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Solar Lentigines
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient receives a single wavelength treatment on one side of their face, and a double wavelength on the other side of their face.
Primary purpose: DEVICE_FEASIBILITY

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale
timeFrame: 1 month post last treatment
Secondary outcomes:
measure: Physician Satisfaction Questionnaire
timeFrame: 1 month post last treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Sadick Research Group
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References: