Fractional CO2 Laser Therapy for Peyronie's Disease

Overseen By Amanda Ross

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Oral agents, Topical agents

Disqualifiers: Penile conditions, Calcified plaque, others

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

Compensation: Varies

Number of Visits: 8

Duration: 18 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using a fractional CO2 laser for men with Peyronie's Disease, which causes painful curvature of the penis due to scar tissue. The goal is to determine if this laser therapy can safely reduce curvature and improve quality of life without surgery. Participants will receive either the laser treatment or a sham (fake) treatment for comparison. Men who have had Peyronie's Disease for at least a year, with a stable condition and a curvature between 30º and 90º, might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that you have not used any oral or topical treatments for Peyronie's Disease in the last 3 months, and no intralesional therapies in the last 3 months. If you are currently using these treatments, you may need to stop them before joining the trial.

What prior data suggests that fractional CO2 laser therapy is safe for treating Peyronie's Disease?

Research has shown that fractional CO2 laser therapy could safely and effectively treat Peyronie's Disease (PD). In earlier studies, men experienced a reduction in penile curvature without major safety concerns. Most patients tolerated the treatment well, though a few reported minor side effects. For instance, one individual experienced penile pain post-treatment, and two other minor issues were noted. Overall, the treatment is considered minimally invasive, posing less risk and not requiring surgery. Promising results after 52 weeks suggest it could be a viable option for managing PD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Peyronie's Disease, which often involve oral medications, injections, or surgery, fractional CO2 laser therapy offers a non-invasive approach. This laser therapy targets the plaque tissue directly, potentially reducing curvature and improving symptoms without the need for more aggressive interventions. Researchers are excited because this method could offer a quicker recovery time and fewer side effects compared to traditional options, making it a promising alternative for patients.

What evidence suggests that fractional CO2 laser therapy might be an effective treatment for Peyronie's Disease?

Research has shown that fractional CO2 laser therapy, which participants in this trial may receive, could be a promising treatment for Peyronie's Disease (PD). In earlier studies, all patients experienced a decrease in the bend of their penis, a common issue in PD. These studies suggest that this laser treatment is safe and non-surgical. Positive results appeared at both 24 and 52 weeks after treatment, with patients noticing improvements. This therapy targets and reduces the abnormal scar tissue, a main problem in PD. Overall, fractional CO2 laser therapy might become a well-tolerated option for people with this condition. ^{2 3 4 6 7}

Who Is on the Research Team?

Luke Witherspoon

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for men with chronic phase Peyronie's Disease, which causes penile deformity and can affect sexual function. Participants will undergo assessments of their condition, including measurements and questionnaires about erectile function and the impact of PD on their lives.

Inclusion Criteria

Signed informed REB-approved consent agreement; signed authorization form to allow disclosure of protected information

Ability to read, complete, and understand the various rating instruments in English

I am a man over 18 in a stable relationship, willing to participate in a study involving sexual health questionnaires.

Exclusion Criteria

Isolated hourglass deformity of the penis without curvature

Calcified plaque as evident by appropriate radiographic evaluation, i.e., penile ultrasound that would prevent treatment with Fractional CO2 Laser

My penile curvature is either less than 30 degrees or more than 90 degrees.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo clinical assessment including penile measurements, curvature assessment with duplex ultrasound, and complete the IIEF-5 and PDQ questionnaires

1 week

1 visit (in-person)

Treatment

Participants receive three fractional CO2 laser therapy sessions at 6-week intervals

18 weeks

3 visits (in-person)

Short-term Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

2 visits (in-person)

Long-term Follow-up

Participants continue to be monitored for safety and effectiveness

52 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fractional CO2 Laser

Trial Overview The study tests Fractional CO2 Laser Therapy as a non-invasive treatment to reduce abnormal collagen in scar tissue caused by Peyronie's Disease. Patients will receive three laser therapy sessions over several weeks with follow-ups at 24 and 52 weeks to evaluate safety and effectiveness.

How Is the Trial Designed?

Group I: Fractional CO2 laser therapy group Experimental Treatment 1 Intervention

Patients will receive three treatments with fractional CO2 laser to identified Peyronie's plaque tissue

Group II: Sham control group Placebo Group 1 Intervention

Patients will receive sham treatment with non-invasive treatment mimicking CO2 laser therapy

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

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

3. 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 ... Although not powered to assess efficacy, a reduction in primary penile curvature was observed in every patient. At baseline, the median degree ...

4. cuaj.ca cuaj.ca/index.php/journal/article/view/8852/6327

View of Fractional CO2 laser for the treatment of Peyronie's ... At one year following initial fractional CO laser therapy, study participants experienced a significant subjective improvement in their ...

5. auajournals.org auajournals.org/doi/10.1097/01.JU.0001008872.42208.7a.02

mp28-02 fractional co 2 laser for the treatment of peyronie's ... Fractional CO2 laser therapy may serve as a safe and minimally invasive therapy for PD, with results at both 24 and 52 weeks being encouraging.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07177833

Title Fractioned CO2 Laser in the Treatment of Chronic ... All men in this study safely experienced reduction in their penile curvature. This will be a phase 1 clinical trial evaluating the safety and ...

7. auajournals.org auajournals.org/doi/pdf/10.1097/01.JU.0001008872.42208.7a.02

Peyronie's Disease Moderated Poster 28 CONCLUSIONS: Fractional CO2 laser therapy may serve as a safe and minimally invasive therapy for PD, with results at both 24 and. 52 weeks being encouraging.