N/A
N=10
Study for the RevLite Laser System for Facial Solar Lentigines
Facial Solar Lentigines
Bottom Line
View on ClinicalTrials.gov: NCT02110108 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale — 0; 1; 3; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Revlite Laser System (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cynosure, Inc.
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale |
0; 1; 3; 3; 6; 4 | — |
| SECONDARY Physician Satisfaction Questionnaire |
3.70; 3.600 | — |
Summary
The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines
Eligibility Criteria
Inclusion Criteria
- Is a healthy male or female between 18 and 60 years old.
- Is Fitzpatrick Skin types I-III
- Is willing to consent to participate in the study.
- 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.
- Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.
Exclusion Criteria
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- Is hypersensitive to light exposure OR takes photo sensitized medication.
- Has active or localized systemic infections.
- 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}).
- Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- 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.
- Has used Accutane within 6 months prior to enrollment.
- Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- Has a history of keloids.
- Has evidence of compromised wound healing.
- Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
Data sourced from ClinicalTrials.gov (NCT02110108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.