755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

Cynosure

Status

Completed

Conditions

Benign Pigmented and Vascular Lesions and Scars

Treatments

Device: 755nm Alex laser

Study type

Interventional

Funder types

Industry

Identifiers

CYN11-PICO_RG2_PL

Details and patient eligibility

About

Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars

Enrollment

43 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Healthy male or female subjects between 18 and 85 years of age.
Subjects with Fitzpatrick skin types I to VI.
Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
Subject who are willing to consent to participate in the study.

4.2 Exclusion Criteria

Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
Hypersensitive to light exposure.
Active localized or systemic infections.
Taking medication for which sunlight is a contraindication.
History of squamous cell carcinoma or melanoma.
History of keloid scarring.
Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
Prior treatment with laser or other devices in treatment area within 3 months
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
Subjects that the physician determines ineligible based on standard of care treatment.