Peyronies DiseasePhase 1NCT07177833
Title Fractioned CO2 Laser in the Treatment of Chronic Phase Peyronie's Disease
A Phase 1 study testing Fractional CO2 laser in people with Peyronies Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Peyronie's Disease (PD) is a fibrosing disorder of the penis where scar tissue (composed of excessive and disorganized collagen) known as a "plaque," forms along the shaft of the penis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronies Disease
- What is being tested?
- Fractional CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2025to 1 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Men 18 or older. For heterosexual men it is required they be in a stable relationship with a female spouse/partner for at least 3 months and willing to have vaginal intercourse for purposes of properly filling out the validated PD Questionnaire.
- 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).
- 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)
- 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.
Who cannot join
- Penile curvature of <30º or >90º
- 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.
- 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.
- Calcified plaque as evident by appropriate radiographic evaluation, i.e., penile ultrasound that would prevent treatment with Fractional CO2 Laser
- Isolated hourglass deformity of the penis without curvature
- 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
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, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y4E9
Amanda Ross, 6137985555, amanross@toh.ca
Luke Witherspoon
About this study
Peyronie's Disease (PD) is a fibrosing 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, and pain during intercourse. Research has shown PD to negatively impact the quality of life and cause significant psychosocial distress for many men.
At present, available medical and surgical treatment modalities for PD have limitations. Intralesional collagenase clostridium histolyticum (CCh) is approved for the reduction of penile curvature in PD, however, its use is restricted to the United States market. Other medical therapies including intralesional verapamil and interferon injections have inconsistent and modest effects while, invasive surgical management with plication or grafting can result in erectile dysfunction, penile length shortening, penile sensory changes, and harvest site complications.
Read more
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 to destroy and reduce abnormal collagen in scarred tissue. Most recently, it has been used in a pilot clinical trial investigating its use in the management of PD. All men in this study safely experienced reduction in their penile curvature.
This will be a phase 1 clinical trial evaluating the safety and feasibility of using a fractional CO2 laser 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 laser therapy sessions at 6 week intervals and will have a short and long-term follow-up of 24 and 52 weeks, respectively.
- Conditions
- Peyronies Disease
- Being tested
- Fractional CO2 laser, Sham (No Treatment)
- Keywords
- Peyronies disease
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laserDevice
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 to destroy and reduce abnormal collagen in scarred tissue.
Sham (No Treatment)Other
Patients will undergo a treatment with a vibratory device capable of mimicking fractional CO2 laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO2 laser therapy group | Experimental | Patients will receive three treatments with fractional CO2 laser to identified Peyronie's plaque tissue Receives: Device: Fractional CO2 laser |
| Sham control group | Sham comparator | Patients will receive sham treatment with non-invasive treatment mimicking CO2 laser therapy Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of fractional CO2 laser therapy application to Peyronie's plaque tissue
Proportion of participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs) following three sessions of fractional CO₂ laser therapy for Peyronie's disease. Safety will be assessed through patient self-reports, clinical evaluations at each visit, and documentation in adverse event logs.
Measured: 52 week follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronies DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luke Witherspoon, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177833
- Sponsor's protocol ID
- 20240299-01H
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title Fractioned CO2 Laser in the Treatment of Chronic Phase Peyronie's Disease
- ClinicalTrials.gov ID
- NCT07177833
- Acronym / sponsor ID
- 20240299-01H
- Conditions
- Peyronies Disease
- Keywords
- Peyronies disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peyronie's Disease (PD) is a fibrosing 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, and pain during intercourse. Research has shown PD to negatively impact the quality of life and cause significant psychosocial distress for many men.
At present, available medical and surgical treatment modalities for PD have limitations. Intralesional collagenase clostridium histolyticum (CCh) is approved for the reduction of penile curvature in PD, however, its use is restricted to the United States market. Other medical therapies including intralesional verapamil and interferon injections have inconsistent and modest effects while, invasive surgical management with plication or grafting can result in erectile dysfunction, penile length shortening, penile sensory changes, and harvest site complications.
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 to destroy and reduce abnormal collagen in scarred tissue. Most recently, it has been used in a pilot clinical trial investigating its use in the management of PD. All men in this study safely experienced reduction in their penile curvature.
This will be a phase 1 clinical trial evaluating the safety and feasibility of using a fractional CO2 laser 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 laser therapy sessions at 6 week intervals and will have a short and long-term follow-up of 24 and 52 weeks, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional CO2 laser therapy group | Experimental | Device: Fractional CO2 laserPatients will receive three treatments with fractional CO2 laser to identified Peyronie's plaque tissue |
| Sham control group | Sham comparator | Other: Sham (No Treatment)Patients will receive sham treatment with non-invasive treatment mimicking CO2 laser therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men 18 or older. For heterosexual men it is required they be in a stable relationship with a female spouse/partner for at least 3 months and willing to have vaginal intercourse for purposes of properly filling out the validated PD Questionnaire.
- 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).
- 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)
- 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.
Key exclusion criteria (6 listed)
- Penile curvature of <30º or >90º
- 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.
- 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.
- Calcified plaque as evident by appropriate radiographic evaluation, i.e., penile ultrasound that would prevent treatment with Fractional CO2 Laser
- Isolated hourglass deformity of the penis without curvature
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional CO2 laserFractional CO2 Laser Therapy is an extra-dermal (applied to the surface of the skin) and non-invasive treatment that involves the use of lasers to destroy and reduce abnormal collagen in scarred tissue. | Device | Fractional CO2 laser therapy group |
| Sham (No Treatment)Patients will undergo a treatment with a vibratory device capable of mimicking fractional CO2 laser therapy | Other | Sham control group |
Primary outcome
Safety of fractional CO2 laser therapy application to Peyronie's plaque tissue
Time frame: 52 week follow up period
Proportion of participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs) following three sessions of fractional CO₂ laser therapy for Peyronie's disease. Safety will be assessed through patient self-reports, clinical evaluations at each visit, and documentation in adverse event logs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Peyronies Disease
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
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Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
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Platelet-Rich Plasma for Peyronie's Disease
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Active, not recruitingPhase 4
Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
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Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luke Witherspoon principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fractional CO2 laser in people with Peyronies Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Ross (6137985555, amanross@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of fractional CO2 laser therapy application to Peyronie's plaque tissue (time frame: 52 week follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.