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

Not Applicable

Completed

• Conditions: Benign Pigmented and Vascular Lesions and Scars
• Interventions: Device: 755nm Alex laser

• Registration Number: NCT01745627
• Lead Sponsor: Cynosure, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2020-10-21
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Results First Posted: 2020-12-23
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

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

4.2 Exclusion Criteria

1. Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule

2. Hypersensitive to light exposure.

3. Active localized or systemic infections.

4. Taking medication for which sunlight is a contraindication.

5. History of squamous cell carcinoma or melanoma.

6. History of keloid scarring.

7. 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.

8. Prior treatment with laser or other devices in treatment area within 3 months

9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.

10. 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.

11. Subjects that the physician determines ineligible based on standard of care treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser Treatment	755nm Alex laser	-

Primary Outcome Measures

Name	Time	Method
Clearance Based on Photographic Scale	3 months post last treatment	This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.

Trial Locations

Locations (1)

Laser & Skin Surgery Center of New York; 🇺🇸 New York, New York, United States