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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to determine which better improves the appearance of acne scars. One treatment uses fractional radiofrequency, while the other employs a laser called 1550-nm fractional photothermolysis. Participants receive both treatments on different sides of their face to compare results. The trial seeks individuals with noticeable acne scars on both sides of their face who haven't recently undergone certain facial treatments. Those with these types of scars and who haven't used specific skin treatments in the past few months may be a good fit. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that 1550-nm fractional photothermolysis is generally well-tolerated. In one study, about 5% of patients experienced mild skin darkening after treatment, though this side effect is uncommon. Other studies have found that this treatment can improve acne scars by tightening and reshaping the skin.

For fractional radiofrequency, research also indicates safety and effectiveness. In one study, independent experts observed a noticeable improvement in acne scars. It is considered a safe option for treating facial acne scars.

Both treatments are currently in a phase 2 trial, meaning they have passed initial safety tests but remain under close monitoring. While minor side effects can occur, research suggests these treatments are generally safe for improving acne scars. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of fractional radiofrequency and 1550-nm fractional photothermolysis for treating acne scars because these methods promise a more targeted and potentially less invasive approach compared to traditional options like chemical peels and dermabrasion. Fractional radiofrequency uses energy waves to stimulate collagen production, which helps to smooth out scars from the inside out. On the other hand, 1550-nm fractional photothermolysis uses laser energy to precisely target scar tissue, promoting skin regeneration and minimizing damage to surrounding areas. Both techniques aim to improve skin texture with minimal downtime, offering patients a faster recovery and potentially more effective results than standard treatments.

What evidence suggests that this trial's treatments could be effective for acne scars?

This trial will compare the effectiveness of 1550-nm fractional photothermolysis and fractional radiofrequency for treating acne scars. Research has shown that the 1550-nm fractional photothermolysis system can significantly improve acne scars, with patients noticing clear improvements and requiring little recovery time. It works particularly well for younger individuals or those taking isotretinoin.

Fractional radiofrequency treatments also show promise. Patients often see improvement in their acne scars about 12 weeks after treatment. This method is considered safe and effective for all skin types, especially with higher power settings. Both treatments in this trial have demonstrated the ability to enhance the appearance of acne scars. ^{1 2 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9884716/

Clinical Factors Affecting the Effectiveness of 1550-nm ... 1550-nm fractional laser treatment for atrophic acne scars was more effective in patients who were younger and taking isotretinoin concurrently.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00641420

Safety and Efficacy of 1550nm Fractional Laser Treatment ... Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18273724/

Fractional photothermolysis for the treatment of acne scars Conclusions: The 1550-nm erbium-doped FP is associated with significant patient-reported improvement in the appearance of acne scars, with minimal downtime.

4. oxforddermatology.com.au oxforddermatology.com.au/wp-content/uploads/2017/09/Acne-Treatment-review-of-a-New-Laser-Fraxel.pdf

Acne-Treatment-review-of-a-New-Laser-Fraxel.pdf Fractional photothermolysis has been shown to improve scars, including surgical scars, hypopigmented scars, and atrophic acne scars. The newest system has the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S174868151500604X

Comparison of four different lasers for acne scars Although the CO2 laser, Er:YAG laser, and AFL improved the acne scars, the CO2 laser had a greater downtime. Three consecutive AFL treatments are as effective ...

6. mdpi.com mdpi.com/2075-1729/15/9/1379

Comparative Effectiveness and Safety of Fractional Laser ... Post-inflammatory hyperpigmentation was observed in 5.42% of FL-treated patients and 4.71% of FRF-treated patients (p = 1.000). Acneiform eruptions occurred in ...

7. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/fpsam.2022.0383

A Network Meta-Analysis of Randomized Controlled Trials A study demonstrated that ablative fractional laser significantly improves acne scars through collagen contraction, remodeling, and skin tightening. The ...

8. journals.lww.com journals.lww.com/ders/fulltext/2021/39040/comparison_of_1550_nm_nonablative_fractional_laser.5.aspx

Comparison of 1550-nm nonablative fractional laser versus... On the 1550-nm NAFL side, 17 patients (73.91%) showed 26%–50% improvement and six patients (26.09%) showed 1%–25% improvement, whereas on the 755-nm picosecond ...