A Pilot Study Testing Fractional Radiofrequency Versus Fractional Photothermolysis for the Treatment of Acne Scars

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01976260
First received: October 15, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to compare the effectiveness of the ePrime fractional radiofrequency system to the 1550-nm fractional photothermolysis system (Fraxel) in the ability to improve acne scar appearance.


Condition Intervention
Cicatrix
Device: Fractional Radiofrequency
Device: 1550-nm Fractional Photothermolysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot, Split-Face Randomized, Evaluator Blinded Study on the Effectiveness of a Bipolar Fractional Radiofrequency System Versus 1550-nm Fractional Photothermolysis for the Treatment of Acne Scars.

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16 [ Time Frame: 1 hour at baseline and week 16 ] [ Designated as safety issue: No ]
    The primary outcome was a blinded rating of the treatment area (Fractional Radiofrequency Versus Fractional Photothermolysis) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16).


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fractional Radiofrequency
Subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. Subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. Follow up visits will take place at week 16, two months following the last treatment visit.
Device: Fractional Radiofrequency
Other Name: ePrime
Active Comparator: 1550-nm Fractional Photothermolysis
Subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. Subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. Follow up visits will take place at week 16, two months following the last treatment visit.
Device: 1550-nm Fractional Photothermolysis
Other Name: Fraxel

Detailed Description:

Participants in this study will be patients at the dermatology clinic with icepick and boxcar acne scars on at least one 2 x 2 cm area on each side of face. Subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. Subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. Follow up visits will take place at week 16, two months following the last treatment visit. This study is a pilot study designed to determine feasibility of these procedures.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects age 18 years and older.
  2. Subjects with bilateral 2x2 cm areas of ice pick and/or boxcar acne scars on their face.
  3. Subjects are in good health.
  4. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion Criteria:

  1. Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months.
  2. Subjects who have received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months.
  3. Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with acne scar treatment with energy devices.
  4. Subjects who are allergic to lidocaine or prilocaine.
  5. Subjects who have a history of abnormal scarring in the treatment area, such as keloid scar formation.
  6. Subjects who have ectropion or or other eyelid disfigurement.
  7. Subjects who have a history of isotretinoin use in the preceding year.
  8. Pregnant or lactating individuals.
  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: NCT01976260

Contacts
Contact: Emily Poon, PhD 312-695-4761 research.nuderm@northwestern.edu

Locations
United States, Illinois
Northwestern University Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
Contact: Emily Poon, PhD    312-695-4761    research.nuderm@norhtwestern.edu   
Principal Investigator: Murad Alam, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01976260     History of Changes
Other Study ID Numbers: STU84041
Study First Received: October 15, 2013
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014