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Study for the RevLite Laser System for Facial Solar Lentigines

NCT ID: NCT02110108

Last Updated: 2021-11-30

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines

Detailed Description

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Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.

Conditions

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Facial Solar Lentigines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each patient receives a single wavelength treatment on one side of their face, and a double wavelength on the other side of their face.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Revlite Laser System- Single Wavelength

Revlite Laser System- 1064nm wavelength will be used on half of the face.

Group Type EXPERIMENTAL

Revlite Laser System

Intervention Type DEVICE

Revlite Laser System for the Treatment of Facial Solar Lentigines

Revlite Laser System- Dual Wavelength

Revlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face.

Group Type EXPERIMENTAL

Revlite Laser System

Intervention Type DEVICE

Revlite Laser System for the Treatment of Facial Solar Lentigines

Interventions

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Revlite Laser System

Revlite Laser System for the Treatment of Facial Solar Lentigines

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Is a healthy male or female between 18 and 60 years old.
2. Is Fitzpatrick Skin types I-III
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.

Exclusion Criteria

1. 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. Is hypersensitive to light exposure OR takes photo sensitized medication.
3. Has active or localized systemic infections.
4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. 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. Has used Accutane within 6 months prior to enrollment.
8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. Has a history of keloids.
11. Has evidence of compromised wound healing.
12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Sadick Research Group

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CYN14-REV-REJUV-NS

Identifier Type: -

Identifier Source: org_study_id