NCT01754246CompletedNot Applicable
Evaluation of the 755nm Alexandrite Laser for Skin Toning and Epidermal Pigmented Lesions in Asian Skin Types
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cynosure, Inc.
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Photographic Evaluation
Study Overview
Brief Summary
The purpose of this study is to assess treatment for facial skin toning and removal of epidermal pigmented lesions for Asian patients using the 755nm Alexandrite laser
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is a healthy male or female between 18 and 85 years old
- •Has unwanted facial epidermal pigmented lesions or desires facial skin toning and wishes to undergo laser treatments.
- •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 Fitzpatrick skin types III to IV.
Exclusion Criteria
- •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.
- •The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- •The subject has active or localized systemic infections
- •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}).
- •The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •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.
- •The subject has used Accutane within 6 months prior to enrollment.
- •The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- •The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- •The subject has a history of keloids or hypertrophic scarring.
- •The subject has evidence of compromised wound healing.
- •The subject has a history of squamous cell carcinoma or melanoma
- •The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- •Allergic to topical lidocaine or topical steroids
Outcomes
Primary Outcomes
Photographic Evaluation
Time Frame: up to 4 months post last treatment
2D Photography to assess progress pre and post treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented LesionsDermal and Epidermal Pigmented LesionsNCT01754233Cynosure, Inc.6
Completed
Not Applicable
Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne ScarsAcne ScarsNCT02103127Cynosure, Inc.20
Completed
Not Applicable
Evaluation of the 755nm Alexandrite Laser for the Treatment of TattoosTattoosNCT01754207Cynosure, Inc.20
Completed
Not Applicable
Evaluation of the 755nm Alexandrite Laser for the Treatment of ScarsScarsNCT01811030Cynosure, Inc.33
Completed
Not Applicable
755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and ScarsBenign Pigmented and Vascular Lesions and ScarsNCT01745627Cynosure, Inc.43