NCT05097469

Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.

Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Female Sexual Dysfunction.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with sexual dysfunction. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Detailed description

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronic files.

Conditions

• Sexual Dysfunction

Interventions

Type	Name	Description
DEVICE	Carbon dioxide laser	3 consecutive sessions of carbon dioxide laser treatment
DEVICE	Sham laser treatment	3 consecutive sessions of sham laser treatment

Timeline

• Start date: 2021-10-04
• Primary completion: 2022-12-31
• Completion: 2023-11-30
• First posted: 2021-10-28
• Last updated: 2022-04-20

Locations

1 site across 1 country: Israel