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

Primary Purpose

Cicatrix

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractional Radiofrequency
1550-nm Fractional Photothermolysis
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern University Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fractional Radiofrequency

1550-nm Fractional Photothermolysis

Arm Description

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.

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.

Outcomes

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
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).

Secondary Outcome Measures

Full Information

First Posted
October 15, 2013
Last Updated
February 17, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01976260
Brief Title
A Pilot Study Testing Fractional Radiofrequency Versus Fractional Photothermolysis for the Treatment of Acne Scars
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional Radiofrequency
Arm Type
Active Comparator
Arm Description
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.
Arm Title
1550-nm Fractional Photothermolysis
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fractional Radiofrequency
Other Intervention Name(s)
ePrime
Intervention Type
Device
Intervention Name(s)
1550-nm Fractional Photothermolysis
Other Intervention Name(s)
Fraxel
Primary Outcome Measure Information:
Title
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16
Description
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).
Time Frame
1 hour at baseline and week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects age 18 years and older. Subjects with bilateral 2x2 cm areas of ice pick and/or boxcar acne scars on their face. Subjects are in good health. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator. Exclusion Criteria: Subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months. Subjects who have received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months. Subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with acne scar treatment with energy devices. Subjects who are allergic to lidocaine or prilocaine. Subjects who have a history of abnormal scarring in the treatment area, such as keloid scar formation. Subjects who have ectropion or or other eyelid disfigurement. Subjects who have a history of isotretinoin use in the preceding year. Pregnant or lactating individuals.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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