Peyronie's DiseasePhase 1NCT07128420

Microneedle Treatment of Chronic Phase Peyronie's Disease: A Pilot Clinical Trial

A Phase 1 study testing Application of 3 sessions of microneedle therapy in people with Peyronie's Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Peyronie's Disease (PD) is a disorder of the penis where scar tissue (composed of excessive and disorganized collagen) known as a "plaque," forms along the shaft of the penis. This plaque can lead to permanent penile deformity (curvature, narrowing, indentation, hinging), loss of penile length, erectile dysfunction… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Peyronie's Disease
What is being tested?: Application of 3 sessions of microneedle therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteCanada
Study dates: 1 Sep 2025to Sep 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Healthy males aged 18 or older in a stable relationship with a female partner/spouse (for at least 3 months and willing to have vaginal intercourse with their female partner/spouse).Non heterosexual men are also included; however they need not fill out the PDQ questionnaire as it pertains to those having intercourse with females.
2. Diagnosis of PD for at least 12 months with evidence of stable disease as determined by the investigator (i.e. no change in penile curve for at least 6 months and absence of pain).
3. Penile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane (must be possible to delineate the single plane of maximal curvature for evaluation)
4. Signed informed IRB-approved consent agreement; signed authorization form to allow disclosure of protected information.
5. Ability to read, complete, and understand the various rating instruments in English.

Who cannot join

1. Penile curvature of <30º or >90º
2. Any conditions affecting the penis such as a chordee in the presence or absence of hypospadias; thrombosis of the dorsal penile artery; infiltration by a benign or malignant mass or an infectious agent; ventral curvature from any cause; presence of an active sexually transmitted disease.
3. Failure to achieve a sufficient 8/10 erection (after prostaglandin E or Trimix administration), in the opinion of the investigator, to accurately measure the penile deformity.
4. Calcified plaque as evident by appropriate radiographic evaluation, i.e., penile ultrasound that would prevent treatment with microneedling.
5. Isolated hourglass deformity of the penis without curvature
6. Treatment or plans to undergo treatment for PD, including but not limited to any previous surgery, oral/topical agents within 3 months, intralesional medical therapies within 3 months, extracorporeal shock wave therapy within 6 months, or use of mechanical devices within 2 weeks before the start of the study

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7. Use of or plans to use a mechanical device to induce a passive erection within 2 weeks before the start of study.
8. Erectile Dysfunction that was unresponsive to PDE5 inhibitors
9. Received an investigation drug or treatment within 30 days before start of the study.
10. At any time, received collagenase clostridium histolyticum (CCH) for the treatment of PD.
11. Currently on anti-coagulation medications.
12. History of HSV

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site

The Ottawa Hospital
Ottawa, Ontario

Other trials in Canada

About this study

This study proposes the use of microneedle treatment of chronic phase PD. Microneedling is a minimally invasive technique that creates tiny injuries in scarred tissues, which encourages a controlled healing process.

This will be a pilot clinical trial evaluating the safety and feasibility of using microneedling treatment in the management of chronic phase PD. Enrolled study participants will undergo an initial clinical assessment of their PD which involves penile measurements at flaccid and erect states, a curvature assessment with duplex ultrasound, and will be asked to complete the International Index of Erectile Function Questionnaire (IIEF-5), and Peyronie's Disease Questionnaire (PDQ). They will then undergo 3-4 treatment sessions at 6-8 week intervals. This will then be followed by a short and long-term follow-up at 24 and 52-54 weeks, respectively.

Conditions: Peyronie's Disease
Being tested: Application of 3 sessions of microneedle therapy
Keywords: Peyronie's disease, Microneedle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Application of 3 sessions of microneedle therapyDevice
Enrolled study participants will receive 3-4 treatments of microneedling to the affected area.
Study participants will microneedling (Fusion Tip Potenza Fractional Radiofrequency Microneedle Electrosurgical Unit, Jeisys Medical Inc, Seoul, KR) at a depth of 2.0 to 2.75mm.

Study groups in NCT07128420
Study group	Role	What they receive
Microneedle application to Peyronie's plaque tissue	Experimental	Not described Receives: Device: Application of 3 sessions of microneedle therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety
Given that this is a pilot study, safety is a critical outcome alongside feasibility and efficacy. Adverse events (AEs) and serious adverse events (SAEs) related to microneedling will be collected, documented, and analyzed to evaluate the safety profile of the intervention. AEs will be assessed at every treatment and follow-up visit through direct questioning, physical examinations, and spontaneous participant reports. Investigators will use a standardized adverse event log to capture the nature, severity, duration, frequency, and outcome of all events.
The incidence of AEs and SAEs will be summarized descriptively using counts and percentages. Events will be categorized by severity (mild, moderate, severe), expectedness (anticipated vs. unanticipated), and relationship to the intervention (definitely, probably, possibly, unlikely, unrelated).
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 2025Sep 2027

First posted19 Aug 2025
Study start1 Sep 2025 (estimated)
Primary completion1 Sep 2027 (estimated)
Study completionSep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07128420
Sponsor's protocol ID: 20250265-01H
Status last verified: Aug 2025
First submitted: 13 Aug 2025
Last updated: 19 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided