Randomized, Controlled Trial With Hybrid Fractional Laser

NCT ID: NCT03647189

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2021-06-15

Brief Summary

This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females

Conditions

Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Subjects will be treated with hybrid fractional laser

Group Type: EXPERIMENTAL

Hybrid Fractional Laser

Intervention Type: DEVICE

Hybrid Fractional Laser

Control Arm

Group Type: PLACEBO_COMPARATOR

Hybrid Fractional Laser

Intervention Type: DEVICE

Hybrid Fractional Laser

Interventions

Hybrid Fractional Laser

Hybrid Fractional Laser

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1. Healthy biological female aged between 40 to 70 years 2. Is post-menopausal with a AND b OR c:

1. No menses for at least 12 months

2. Follicle-stimulating hormone (FSH) level over 40mlU/mL

3. Has had a bilateral oophorectomy at least 12 months ago with no hormone replacement 3. Is experiencing at least two self-reported symptoms of GSM, such as

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1. Vaginal irritation in the absence of infection

2. Chronic burning sensation

3. Chronic itching in the absence of infection

4. Recurring urinary tract infections (UTIs)

5. Vaginal dryness during sexual activity

6. Pain during sexual activity (dyspareunia) 4. Has been experiencing symptoms of GSM for greater than 3 months 5. Is unable due to a medical contraindication or unwilling to receive hormone-based vaginal therapy 6. Early menopause after breast cancer 7. Normal and up to date pap smear, if applicable 8. Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve 9. Can read, understand and sign informed consent form 10. Has indicated willingness to participate in the study by signing an informed consent form 11. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria

• 1. Undiagnosed abnormal genital bleeding 2. Has history of pelvic surgery or other energy-based vaginal therapy within 12 months prior to enrollment 3. Previous use of topical estrogen therapy within the last 6 months 4. Has used vaginal creams, moisturizers, lubricants or homeopathic preparations, or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment 5. Has history of heart failure 6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q) 7. Has an active sexually transmitted infection (STI) 8. Has signs or symptoms of vulvitis/vaginitis 9. Has signs or symptoms of acute urinary tract infection (UTI) 10. Has participated in any clinical trial involving an investigational drug or procedure within past 30 days 11. The investigator feels that for any reason the subject is not eligible to participate in the study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sciton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Miamim Dermatology

Miami, Florida, United States

Countries

United States

Other Identifiers

DIVA-001

Identifier Type: -

Identifier Source: org_study_id