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
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

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014