Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease

NCT04326465 | Completed FDA Device

• 1 other identifier: H18-02482
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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 assigned to receive Fractional Carbon Dioxide Laser Therapy at 10-15% laser density coverage.

Conditions

Peyronies Disease

Keywords

Peyronies Disease; Fractionated Carbon Dioxide Laser

Outcome Measures

Primary Outcomes (1)

• Measured reduction in penile curvature

  Penile measurements will be collected at erect states. Penile measurements will be conducted at the screening visit (Baseline) and at the follow-up study visits (Week 18, 24, \& 52).

  Change in penile measurements (Baseline vs. Week 18, 24, & 52).

Secondary Outcomes (2)

• International Index of Erectile Function Questionnaire

  Change in International Index of Erectile Function Questionnaire score (Baseline vs. Week 18, 24, & 52).

• Peyronie's Disease Questionnaire

  Change in Peyronie's Disease Questionnaire score (Baseline vs. Week 18, 24, & 52).

Study Arms (1)

Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage

EXPERIMENTAL

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.

Device: Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage

Interventions

Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage DEVICE

Fractional Carbon Dioxide Laser Therapy is an ablative therapy where abnormal collagen in scarred tissue is destroyed to permit the formation of more organized collagen. Previous studies have demonstrated its efficacy in treating medical conditions (ex. hypertrophic scars) similar to Peyronies Disease. There is evidence that Fractional Carbon Dioxide Laser Therapy has the ability to target and alter the molecular pathways that are similar to the ones that lead to Peyronie's Disease.

Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males age 18 or older in a stable relationship with a female partner/spouse (for at least 3 months and willing to have vaginal intercourse with that female partner/spouse.
• Diagnosis of Peyronie's Disease for at least 12 months with evidence of stable disease as determined by the investigator.
• Penile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane (must have been possible to delineate the single plane of maximal curvature for evaluation).
• Signed informed Ethics-approved consent agreement; signed authorization form to allow disclosure of protected information.
• Ability to read, complete, and understand the various rating instruments in English.

You may not qualify if:

• 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; known active hepatitis B or C; known immune deficiency disease (including Human Immunodeficiency Virus).
• Failure to achieve a sufficient erection (after prostaglandin 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 Carbon Dioxide Laser.
• Isolated hourglass deformity of the penis without curvature.
• Treatment or plans to undergo treatment for Peyronie's Disease, 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.
• Use of or plans to use a mechanical devices to induce a passive erection within 2 weeks before the start of study.
• Erectile dysfunction that was unresponsive to Phosphodiesterase inhibitors.
• Received an investigation drug or treatment within 30 days before start of the study.
• At any time, received Collagenase clostridium histolyticum for the treatment of Peyronie's Disease.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Diamond Health Care Centre

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ryan Flannigan, MD

  UBC Faculty of Medicine - Department of Urologic Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Efficacy and safety trial for Fractional CO2 Laser Therapy with pre- and post-treatment comparisons (3 laser therapy sessions over 12 weeks in men with Peyronie's Disease).

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: March 30, 2020
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

CA (1)