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Active, Not Recruiting

NCT Number: NCT01976260

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractional radiofrequency

Device

Other names: ePrime

1550-nm Fractional Photothermolysis

Device

Other names: Fraxel

Primary outcomes

  1. 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

    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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2013
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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