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

Primary Purpose

Acne Scars

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
RevLite Q-Switched Nd:YAG Laser
Sponsored by
ConBio, a Cynosure Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acne treatment

Arm Description

Treatment of acne scars

Outcomes

Primary Outcome Measures

Global Acne Scarring Classification

Secondary Outcome Measures

Subject Satisfaction
5 point Likert scale

Full Information

First Posted
October 14, 2010
Last Updated
November 27, 2012
Sponsor
ConBio, a Cynosure Company
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1. Study Identification

Unique Protocol Identification Number
NCT01221922
Brief Title
Laser Treatment of Acne Scars in Fitzpatrick Skin Types III-VI
Official Title
A Study of the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser for the Treatment of Acne Scars in Fitzpatrick Skin Types III-VI
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConBio, a Cynosure Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acne treatment
Arm Type
Experimental
Arm Description
Treatment of acne scars
Intervention Type
Device
Intervention Name(s)
RevLite Q-Switched Nd:YAG Laser
Intervention Description
Laser treatment once every 2 weeks for a total of 10 treatments.
Primary Outcome Measure Information:
Title
Global Acne Scarring Classification
Time Frame
3 Months post final treatment
Secondary Outcome Measure Information:
Title
Subject Satisfaction
Description
5 point Likert scale
Time Frame
3 Months post final treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niwat Polnikorn, MD
Organizational Affiliation
Kasemrad Aesthetic Center, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

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

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