Fractional Radiofrequency vs Fractional Photothermolysis for Acne Scars

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: Isotretinoin

Disqualifiers: Local infections, Abnormal scarring, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have used isotretinoin in the past year, you cannot participate.

What data supports the effectiveness of the treatment 1550-nm Fractional Photothermolysis and Fractional Radiofrequency for acne scars?

Research shows that the 1550-nm fractional laser improves acne scars, making them smoother and more even, with patients reporting satisfaction and minimal side effects. Additionally, fractional photothermolysis has been proven to provide satisfactory results for atrophic acne scars. ^{1 2 3 4 5}

Is fractional radiofrequency and fractional photothermolysis safe for treating acne scars?

Both fractional radiofrequency and fractional photothermolysis have been shown to be safe for treating acne scars, with minimal side effects reported in studies. ^{1 2 5 6 7}

How does the treatment of fractional radiofrequency and 1550-nm fractional photothermolysis for acne scars differ from other treatments?

This treatment combines fractional radiofrequency, which heats deeper skin layers while sparing the surface, with 1550-nm fractional photothermolysis, a laser that targets specific skin areas to improve acne scars. This combination aims to enhance effectiveness by addressing both deep and surface skin layers, offering a unique approach compared to other treatments that may focus on only one layer. ^{1 3 8 9 10}

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults with specific types of acne scars on their face who are in good health and can give informed consent. It's not for those allergic to local anesthetics like lidocaine, have eyelid disfigurements, recent facial treatments (injectables or resurfacing), pregnant or breastfeeding individuals, recent isotretinoin users, or a history of abnormal scarring.

Inclusion Criteria

You have acne scars on your face that are at least 2x2 cm in size and have a specific shape, either "ice pick" or "boxcar".

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

You are allergic to lidocaine or prilocaine.

You have an eyelid abnormality such as ectropion or a disfigurement.

You have had facial injections or resurfacing procedures within the past 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional radiofrequency or 1550-nm fractional photothermolysis treatments at baseline, week 4, and week 8

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person)

Treatment Details

Interventions

• 1550-nm Fractional Photothermolysis
• Fractional Radiofrequency

Trial Overview The study compares two acne scar treatments: ePrime fractional radiofrequency and Fraxel (1550-nm fractional photothermolysis). Participants will receive one treatment on each side of their face to see which improves the appearance of acne scars better.

Participant Groups

Group I: 1550-nm Fractional Photothermolysis Active Control 1 Intervention

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.

Group II: Fractional Radiofrequency Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

In a study involving 40 patients, both the Er:Glass fractional laser and fractional radiofrequency microneedle device significantly improved atrophic acne scars, with scar severity scores improving by 25.0% and 18.6%, respectively, after three treatments.

While the Er:Glass fractional laser was found to be more effective overall, the fractional radiofrequency microneedle device provided good patient adherence and shorter recovery time, making it a viable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study on efficacy and safety of 1550 nm Er:Glass fractional laser and fractional radiofrequency microneedle device for facial atrophic acne scar. Chae, WS., Seong, JY., Jung, HN., et al.[2022]

In a study of 87 patients with moderate to severe acne scars treated with nonablative fractional photothermolysis using a 1540-nm Erbium glass fiber laser, 92% of patients experienced marked improvement six months after treatment.

The treatment was found to be safe and effective, as it promoted the replacement of coarse collagen with healthier collagen similar to that found in normal skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonablative fractional photothermolysis for acne scars: clinical and in vivo microscopic documentation of treatment efficacy. Bencini, PL., Tourlaki, A., Galimberti, M., et al.[2022]

In a study of 58 Egyptian patients with moderate to severe acne atrophic scars, both fractional CO2 and fractional non-ablative 1540 nm erbium lasers were found to be effective treatments, with high patient satisfaction rates.

The fractional CO2 laser showed slightly higher efficacy in improving scar appearance, while the non-ablative erbium laser provided benefits of less pain and shorter recovery time, making both options viable for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablative Fractional 10 600 nm Carbon Dioxide Laser Versus Non-ablative Fractional 1540 nm Erbium-Glass Laser in Egyptian Post-acne Scar patients. Elsaie, ML., Ibrahim, SM., Saudi, W.[2020]

A study involving 41 patients demonstrated that combined fractional carbon dioxide (FCL) and radiofrequency (FRFL) laser treatment significantly reduced acne scar severity, particularly for atrophic scars, as assessed by clinical scoring after one month.

The treatment was found to be effective and well-tolerated, with minimal and acceptable side effects, indicating it is a safe option for improving acne scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of fractional carbondioxyde laser and microneedle radiofrequency on acne scars. Canpolat, F., Koc, E., Kartal, SP.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparative study on efficacy and safety of 1550 nm Er:Glass fractional laser and fractional radiofrequency microneedle device for facial atrophic acne scar. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 1550-nm fractional laser in the treatment of acne scars in Chinese patients: A split-face comparative study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Ablative fractional erbium-doped yttrium aluminum garnet laser with coagulation mode for the treatment of atrophic acne scars in Asian skin. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Fractional nonablative 1,540-nm laser resurfacing of atrophic acne scars. A randomized controlled trial with blinded response evaluation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A 2940 nm fractional photothermolysis laser in the treatment of acne scarring: a pilot study in China. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Nonablative fractional photothermolysis for acne scars: clinical and in vivo microscopic documentation of treatment efficacy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fractional radiofrequency for the treatment and reduction of acne scarring: A prospective study. [2022]

8. Iran pubmed.ncbi.nlm.nih.gov

Ablative Fractional 10 600 nm Carbon Dioxide Laser Versus Non-ablative Fractional 1540 nm Erbium-Glass Laser in Egyptian Post-acne Scar patients. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of combined fractional radiofrequency and fractional laser treatment for acne scars in Asians. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The effectiveness of fractional carbondioxyde laser and microneedle radiofrequency on acne scars. [2022]