CO2 Laser Therapy for Peyronie's Disease

Overseen By Justin Chan, BMSc

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Phosphodiesterase inhibitors

Disqualifiers: Penile conditions, Erectile dysfunction, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser therapy for Peyronie's Disease, a condition that causes a curved penis and can make sex painful or difficult. The treatment uses a special laser called Fractional Carbon Dioxide Laser Therapy to determine if it reduces the curvature. Suitable candidates have had a stable case of Peyronie's Disease for at least a year, with a penile curve between 30º and 90º.

As an unphased trial, this study provides patients the chance to explore innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used oral or topical agents for Peyronie's Disease within 3 months before the study.

What prior data suggests that Fractional Carbon Dioxide Laser Therapy is safe for treating Peyronie's Disease?

Research has shown that Fractional Carbon Dioxide (CO2) Laser Therapy is generally safe for treating Peyronie's Disease. In one study, only 9% of patients experienced complications, indicating the treatment is well-tolerated. By week 6, one patient reported penile pain, and by week 12, two other minor issues occurred. These problems were not serious, demonstrating the therapy's safety. Overall, this laser treatment is considered minimally invasive, as it doesn't require surgery or deep skin penetration. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fractional Carbon Dioxide Laser Therapy is unique because it offers a non-invasive approach to treating Peyronie's Disease, unlike standard treatments that often involve medication or surgery. This laser therapy works by using controlled laser energy to potentially remodel scar tissue and improve penile curvature, which is a new mechanism of action compared to the typical methods such as oral medications or injections. Researchers are excited about this treatment because it combines laser therapy with topical triamcinolone, which may enhance the effectiveness of the treatment and reduce the need for more invasive interventions. Plus, the promise of fewer side effects and quicker recovery times makes this a promising option for patients.

What evidence suggests that Fractional Carbon Dioxide Laser Therapy might be an effective treatment for Peyronie's Disease?

Research has shown that Fractional Carbon Dioxide Laser Therapy, which participants in this trial will receive, might be a promising treatment for Peyronie's Disease, a condition that causes the penis to curve. Earlier studies demonstrated positive results over a year. The therapy proved safe, with only about 9% of patients experiencing any issues. As a minimally invasive treatment, it does not involve surgery and uses a laser on the skin's surface. With encouraging results from initial studies, this therapy offers hope as a new treatment option for those with Peyronie's Disease. ^{1 3 4 5 6}

Who Is on the Research Team?

Ryan Flannigan, MD

Principal Investigator

UBC Faculty of Medicine - Department of Urologic Sciences

Are You a Good Fit for This Trial?

This trial is for healthy males aged 18 or older, diagnosed with Peyronie's Disease for at least a year and have stable disease. They must be in a stable relationship, able to read and understand English, and willing to sign consent forms. Men with penile curvature between 30º-90º are eligible.

Inclusion Criteria

You are willing to have vaginal intercourse with a female partner/spouse

Penile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane.

You have Peyronie's disease for at least 12 months with evidence of stable disease as determined by the investigator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants receive Fractional Carbon Dioxide Laser Therapy sessions every six weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up appointments at Week 18, 24, and 52

52 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fractional Carbon Dioxide Laser Therapy

Trial Overview The study tests Fractional Carbon Dioxide Laser Therapy as a treatment for Peyronie's Disease. Participants will receive this therapy at a laser density coverage of 10-15%. It's designed to see if the laser can help reduce symptoms of the disease.

How Is the Trial Designed?

Group I: Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage Experimental Treatment 1 Intervention

Study participants with Peyronies Disease will be treated with a Fractional Carbon Dioxide Laser set at a 10-15% laser density. The patient will receive three laser therapy sessions over 12 weeks (one session every four weeks). Following each session, topical triamcinolone will be applied to the treated area.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

In a study of 918 patients with Peyronie's disease, treatment with collagenase Clostridium histolyticum resulted in a significant improvement in penile curvature, reducing the average curvature from 48.2 degrees to 32.9 degrees, which is a 30.1% improvement.

The treatment was found to be safe, with only 9% of patients experiencing complications, and the number of treatment cycles was positively correlated with the degree of curvature improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intralesional Collagenase Clostridium histolyticum Causes Meaningful Improvement in Men with Peyronie's Disease: Results of a Multi-Institutional Analysis. Hellstrom, WJG., Tue Nguyen, HM., Alzweri, L., et al.[2019]

Collagenase clostridium histolyticum (CCH) is effective in treating ventral penile curvatures caused by Peyronie's Disease, with significant improvements observed in curvature after treatment, particularly for ventral (49% improvement) and lateral (38% improvement) curvatures compared to dorsal (25% improvement).

The treatment was found to have a similar safety profile across different curvature directions, with no urethral complications reported, indicating that CCH is a safe option for men with ventral Peyronie's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men With Ventral Curvatures. Alom, M., Meng, Y., Sharma, KL., et al.[2020]

Collagenase clostridium histolyticum (CCH) therapy significantly improved penile curvature in men with Peyronie's disease over a 5-year period, with improvements of 20.9° in those with no calcification and similar results in those with stippled or interfering calcification.

No long-term safety issues were identified, indicating that CCH is a safe and effective nonsurgical treatment option for men with Peyronie's disease, even in cases of plaque calcification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Curvature Deformity Characterization in Men Previously Treated With Collagenase Clostridium Histolyticum for Peyronie's Disease, Subgrouped by Penile Plaque Calcification. Goldstein, I., McLane, MP., Xiang, Q., et al.[2022]

A 69-year-old man with penile lichen sclerosus underwent five treatments with a fractional micro-ablative CO2 laser, showing significant symptom improvement after the first session.

Complete clinical remission was achieved 14 weeks after the final treatment, suggesting that this laser therapy could be an effective alternative to traditional treatments like topical steroids or circumcision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Micro-ablative CO2 Laser as Therapy in Penile Lichen Sclerosus. Campolmi, P., Cannarozzo, G., Bennardo, L., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39418492/

Fractional CO2 laser for the treatment of Peyronie's ... With encouraging results at 52 weeks, fractional CO 2 laser therapy may serve as a well-tolerated and minimally invasive therapy for PD in the future.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04326465

Fractionated Carbon Dioxide Laser Therapy for Treatment ... This is a pilot study that evaluates the use of Fractional Carbon Dioxide Laser Therapy in the treatment of Peyronie's Disease. Study participants will be ...

3. withpower.com withpower.com/trial/phase-penile-induration-4-2021-209b9

CO2 Laser Therapy for Peyronie's Disease The treatment was found to be safe, with only 9% of patients experiencing complications, and the number of treatment cycles was positively correlated with the ...

4. auanews.net auanews.net/issues/articles/2024/november-2024/aua-award-winners-evaluating-a-novel-fractional-co2-laser-in-the-treatment-of-chronic-phase-peyronies-disease

AUA AWARD WINNERS Evaluating a Novel Fractional ... Fractional CO2 laser therapy would represent a potential new therapeutic option for PD patients. Positive results will set the stage for a large ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07177833

Title Fractioned CO2 Laser in the Treatment of Chronic ... Fractional CO2 Laser Therapy is an extra-dermal (applied to the surface of the skin) and non-invasive treatment that involves the use of lasers ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04326465

Fractionated Carbon Dioxide Laser Therapy for Treatment ... This study investigates the use of a non-invasive and extra-dermal Fractional Carbon Dioxide Laser Therapy to treat chronic phase Peyronie's Disease.