Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

NCT ID: NCT01775722

Last Updated: 2022-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-08-31

Brief Summary

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Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.

Detailed Description

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The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.

Conditions

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Port-Wine Stain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulsed Dye Laser

port wine stain treatment using Pulse Dye Laser

Group Type OTHER

Pulsed Dye Laser

Intervention Type DEVICE

port wine stain

Bipolar Radiofrequency&Pulsed Dye Laser

Port wine stain using Combined Bipolar Radiofrequency\&Pulsed Dye Laser

Group Type EXPERIMENTAL

Combined Bipolar Radiofrequency&Pulsed Dye Laser

Intervention Type DEVICE

Combined Bipolar Radiofrequency\&Pulsed Dye Laser Treatment

Interventions

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Pulsed Dye Laser

port wine stain

Intervention Type DEVICE

Combined Bipolar Radiofrequency&Pulsed Dye Laser

Combined Bipolar Radiofrequency\&Pulsed Dye Laser Treatment

Intervention Type DEVICE

Other Intervention Names

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candela-Laser

Eligibility Criteria

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Inclusion Criteria

1. Port Wine Stain suitable for comparison testing
2. Age \> 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
3. Apparent good health as documented by medical history
4. Ability to understand and carry out subject instructions

Exclusion Criteria

1. History of photodermatoses or skin cancer
2. Any therapy within the previous two months to the proposed port wine stain treatment sites
3. Current participation in any other investigational drug or device evaluation
4. Concurrent use of known photosensitizing drugs
5. Inability to understand and carry out instructions
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Candela Corporation

INDUSTRY

Sponsor Role collaborator

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J. Stuart Nelson, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute, UCI

Locations

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Beckman Laser Institute Medical Clinic

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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20129092

Identifier Type: -

Identifier Source: org_study_id

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