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Evaluation of the 755nm Alexandrite Laser for Skin Toning and Epidermal Pigmented Lesions in Asian Skin Types

NCT ID: NCT01754246

Last Updated: 2020-10-27

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to assess treatment for facial skin toning and removal of epidermal pigmented lesions for Asian patients using the 755nm Alexandrite laser

Detailed Description

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Conditions

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Epidermal Pigmented Lesions Skin Toning

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants are put into two groups (Pigmented Lesions/Skin Toning) to test prototype design and operating specifications. It is not a full clinical trial.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Alexandrite Laser for Skin Toning

755 nm Alexandrite Laser for Skin Toning

Group Type EXPERIMENTAL

755nm Alexandrite Laser

Intervention Type DEVICE

755nm Alexandrite laser for treatment of epidermal pigmented lesions and skin toning in Asian skin types

Alexandrite Laser for Pigmented Lesions

755nm Alexandrite Laser for Epidermal Pigmented Lesions

Group Type EXPERIMENTAL

755nm Alexandrite Laser

Intervention Type DEVICE

755nm Alexandrite laser for treatment of epidermal pigmented lesions and skin toning in Asian skin types

Interventions

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755nm Alexandrite Laser

755nm Alexandrite laser for treatment of epidermal pigmented lesions and skin toning in Asian skin types

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 facial epidermal pigmented lesions or desires facial skin toning 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 being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has Fitzpatrick skin types III 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 or hypertrophic scarring.
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. Allergic to topical lidocaine or topical steroids
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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Skin Care Physicians

Chestnut Hill, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CYN12-PICO-PLASIAN

Identifier Type: -

Identifier Source: org_study_id