Laser Treatment of Acne Scars in Fitzpatrick Skin Types III-VI

NCT ID: NCT01221922

Last Updated: 2012-11-28

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to evaluate the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types (Fitzpatrick Skin Types III, IV, V and VI).

Detailed Description

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Conditions

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Acne 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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Acne treatment

Treatment of acne scars

Group Type EXPERIMENTAL

RevLite Q-Switched Nd:YAG Laser

Intervention Type DEVICE

Laser treatment once every 2 weeks for a total of 10 treatments.

Interventions

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RevLite Q-Switched Nd:YAG Laser

Laser treatment once every 2 weeks for a total of 10 treatments.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years or older with Fitzpatrick Skin Type III, IV, V or VI
* Evidence of atrophic scarring

Exclusion Criteria

* Pregnancy, lactating or planning to become pregnant during the study
* History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
* Any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
* Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
* Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering the study
* Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
* Subject may be unreliable for the study. This includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
* Use of oral or topical isotretinoin therapy within 6 months prior to enrollment. With the exception of isotretinoin, subjects will be allowed to continue their topical or oral acne medications during the trial
* Need to be exposed to artificial tanning devices or excessive sunlight during the trial
* Prior treatment with parenteral gold therapy
* Diabetes Type I or II, Lupus, Scleroderma or a similar immune system disorder
* Subject does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected filler/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study
* Underlying silicone or other nonabsorbable fillers in the treatment area or has had filler (e.g., collagen, fat) injections within the past 3 months
* History of keloidal scarring or nodulocystic acne
* Phenol or chemical peel or dermabrasion to the the treatment area within the past 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ConBio, a Cynosure Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niwat Polnikorn, MD

Role: PRINCIPAL_INVESTIGATOR

Kasemrad Aesthetic Center, Thailand

Locations

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Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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C67-10-A

Identifier Type: -

Identifier Source: org_study_id