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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier:
NCT01221922
First received: October 14, 2010
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Acne Scars
Device: RevLite Q-Switched Nd:YAG Laser

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • Global Acne Scarring Classification [ Time Frame: 3 Months post final treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject Satisfaction [ Time Frame: 3 Months post final treatment ] [ Designated as safety issue: No ]
    5 point Likert scale


Enrollment: 20
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acne treatment
Treatment of acne scars
Device: RevLite Q-Switched Nd:YAG Laser
Laser treatment once every 2 weeks for a total of 10 treatments.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221922

Locations
Thailand
Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital
Bangkok, Thailand
Sponsors and Collaborators
ConBio, a Cynosure Company
Investigators
Principal Investigator: Niwat Polnikorn, MD Kasemrad Aesthetic Center, Thailand
  More Information

No publications provided

Responsible Party: Cynosure, Inc. ( ConBio, a Cynosure Company )
ClinicalTrials.gov Identifier: NCT01221922     History of Changes
Other Study ID Numbers: C67-10-A
Study First Received: October 14, 2010
Last Updated: November 27, 2012
Health Authority: Thailand: Ethical Committee

ClinicalTrials.gov processed this record on September 30, 2014