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

NCT01976260 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: STU84041
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix

Outcome Measures

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

  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).

  1 hour at baseline and week 16

Study Arms (2)

Fractional Radiofrequency

ACTIVE COMPARATOR

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

1550-nm Fractional Photothermolysis

ACTIVE COMPARATOR

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

Interventions

Fractional Radiofrequency DEVICE

Also known as: ePrime

Fractional Radiofrequency

1550-nm Fractional Photothermolysis DEVICE

Also known as: Fraxel

1550-nm Fractional Photothermolysis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: November 5, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)