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

NCT ID: NCT01745627

Last Updated: 2020-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Conditions

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Benign Pigmented and Vascular Lesions and Scars

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser Treatment

Group Type EXPERIMENTAL

755nm Alex laser

Intervention Type DEVICE

Interventions

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755nm Alex laser

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cynosure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

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Laser & Skin Surgery Center of New York

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CYN11-PICO_RG2_PL

Identifier Type: -

Identifier Source: org_study_id