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Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars

NCT ID: NCT01813786

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.

Detailed Description

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Conditions

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Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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755nm Alexandrite Laser with Handpiece 2

Focusing energy on skin

Group Type EXPERIMENTAL

755nm Alexandrite Laser with handpiece 2

Intervention Type DEVICE

Focusing energy on skin

755nm Alexandrite Laser with handpiece 3

Focusing energy on skin

Group Type EXPERIMENTAL

755nm Alexandrite Laser with handpiece 3

Intervention Type DEVICE

Focusing energy on skin

755nm Alexandrite laser with handpiece 1

Focusing energy on skin

Group Type EXPERIMENTAL

755nm Alexandrite Laser with handpiece 1

Intervention Type DEVICE

focusing energy at skin surface

Interventions

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755nm Alexandrite Laser with handpiece 2

Focusing energy on skin

Intervention Type DEVICE

755nm Alexandrite Laser with handpiece 1

focusing energy at skin surface

Intervention Type DEVICE

755nm Alexandrite Laser with handpiece 3

Focusing energy on skin

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Is a healthy male or female between 18 and 85 years old
2. Has unwanted scars not including atrophic scars and wishes to undergo laser treatments.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has Fitzpatrick skin types I to IV.

Exclusion Criteria

1. 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.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections.
4. 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}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. 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.
7. The subject has used Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloids.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. The subjects has an allergy to lidocaine and epinephrine.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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CYN12-PICO-CAPHST-07

Identifier Type: -

Identifier Source: org_study_id