N/A N=42 Treatment

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

Benign Pigmented and Vascular Lesions and Scars

Bottom Line

View on ClinicalTrials.gov: NCT01745627 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Clearance Based on Photographic Scale — 2; 2; 4; 7 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 755nm Alex laser (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cynosure, Inc.
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Clearance Based on Photographic Scale	2; 2; 4; 5	—
PRIMARY Clearance Based on Photographic Scale	2; 2; 4; 5	—

Summary

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01745627). 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.