Microneedle Treatment for Curvature of the Penis

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Anti-coagulation medications

Disqualifiers: Penile conditions, Calcified plaque, Erectile dysfunction, others

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

Compensation: Varies

Number of Visits: 7

Duration: 18-32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new microneedle treatment for men with Peyronie's Disease. Peyronie's Disease causes scar tissue in the penis, leading to curvature and pain, which can impact quality of life. The trial aims to determine if microneedling, a technique that creates tiny injuries to promote healing, can safely and effectively treat this condition. Suitable candidates for the trial are men who have had a stable case of Peyronie's Disease for at least 12 months, with a noticeable penile curve between 30º and 90º. Participants should be in a stable relationship and able to complete assessments in English.

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 treatment.

Will I have to stop taking my current medications?

The trial requires that you have not used oral or topical agents for Peyronie's Disease within 3 months, intralesional therapies within 3 months, or mechanical devices within 2 weeks before starting. If you are on anti-coagulation medications, you cannot participate.

What prior data suggests that this microneedle treatment is safe for Peyronie's Disease?

Research has shown that microneedling might be a promising treatment for Peyronie's Disease (PD). In some studies, patients reported improvements: 25% noticed better curvature, 56% saw improvements in scar tissue, and all reported less pain. However, these results are not certain.

This is a Phase 1 trial, focusing primarily on safety. Phase 1 trials are the first stage of testing a treatment in humans. These trials are usually small and closely monitored. Microneedling involves making tiny injuries in the scar tissue to initiate a healing process.

While specific safety data from past studies on microneedling for PD is lacking, the procedure is generally well-tolerated in other applications. Participants in this trial will have several check-ups to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Peyronie's Disease?

Unlike the standard treatments for Peyronie's disease, which often involve oral medications, injections, or surgical intervention, the microneedle treatment offers a unique delivery method. This approach directly targets the Peyronie's plaque tissue with precision, potentially minimizing side effects associated with more invasive procedures. Researchers are excited about this treatment because it could provide a less invasive, more localized option that directly addresses the fibrous plaque, possibly leading to improved outcomes with fewer complications.

What evidence suggests that microneedle treatment might be an effective treatment for Peyronie's Disease?

Research has shown that microneedle treatment, which participants in this trial will receive, might help reduce the bend and size of scar tissue in Peyronie's Disease (PD). One study found that the bend in the penis decreased from 30.4° to 25.0°, and the scar tissue became smaller. Some patients also experienced improvements in narrowing and bending with similar treatments. These findings suggest that microneedling could help manage PD symptoms by encouraging controlled healing in the scarred area. While more research is needed, the early results are promising for those considering this treatment for PD. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men with Peyronie's Disease, which causes a curved penis due to scar tissue. Participants should be in the chronic phase of the disease and willing to undergo microneedle therapy sessions and follow-up assessments.

Inclusion Criteria

I am a healthy male, 18 or older, in a stable relationship, willing to have vaginal intercourse.

I have had Peyronie's disease for over a year with no worsening.

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

Exclusion Criteria

History of HSV

I am currently taking blood thinners.

I cannot achieve a strong enough erection for accurate deformity measurement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Assessment

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

1 week

1 visit (in-person)

Treatment

Participants receive 3-4 microneedling treatment sessions at 6-8 week intervals

18-32 weeks

3-4 visits (in-person)

Short-term Follow-up

Participants are monitored for safety and effectiveness 24 weeks after treatment

1 week

1 visit (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness 52-54 weeks after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Microneedle Treatment

Trial Overview The study tests if microneedling, a minimally invasive technique that promotes healing by creating tiny injuries in scarred tissues, can help manage Peyronie's Disease. It involves initial assessments, 3-4 treatment sessions over several weeks, and follow-ups after 24 and up to 54 weeks.

How Is the Trial Designed?

Group I: Microneedle application to Peyronie's plaque tissue Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9901485/

Peyronie's Disease: An Outcomes-Based Guide to Non ... 85 The group reported statistically significant reductions in degree of curvature (30.4° vs 25.0°), plaque size (1.78 vs 1.53 cm), and PD ...

2. withpower.com withpower.com/trial/phase-1-peyronie39s-disease-8-2025-918c7

Microneedle Treatment for Curvature of the Penis It involves initial assessments, 3-4 treatment sessions over several weeks, and follow-ups after 24 and up to 54 weeks.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2090598X13000363

A critical analysis of the surgical outcomes for the treatment ... Results at the 1 year follow-up showed complete resolution of the penile curvature in 76% of patients, with 84% maintaining sufficient erectile function for ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iju.14230

Peyronie's disease: Contemporary evaluation and ... Subjective improvements in narrowing and curvature were reported in 100% and 43%, respectively. A subsequent study reported outcomes for 140 men ...

5. mdpi.com mdpi.com/2076-3271/7/9/96

Medical Management of Peyronie's Disease: Review of the ... Moreover, in a case series of 115 patients treated with CHH, mean curvature improvement was 28% in patients without calcification and 10% in those with severe ...

6. ctv.veeva.com ctv.veeva.com/study/microneedle-treatment-of-chronic-phase-peyronies-disease-a-pilot-clinical-trial

Microneedle Treatment of Chronic Phase Peyronie's Disease This will be a pilot clinical trial evaluating the safety and feasibility of using microneedling treatment in the management of chronic phase PD ...

7. auanet.org auanet.org/guidelines-and-quality/guidelines/peyronies-disease-guideline

Peyronie's Disease Guideline In the observational study, 25% of patients reported curvature improvement, 56% reported plaque improvement, and 100% reported pain improvement. Uncertainty ...

8. jmedicalcasereports.biomedcentral.com jmedicalcasereports.biomedcentral.com/articles/10.1186/s13256-022-03614-1

Patients with Peyronie's disease achieve complete plaque ... This study demonstrates that our multimodal therapy is able to completely regress plaque, as demonstrated in our previously published article.