Randomized, Controlled Trial With Hybrid Fractional Laser

Randomized, Controlled Trial With Hybrid Fractional Laser for Vulvovaginal Atrophy in Breast Cancer Survivors and Menopausal Females

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

Study Overview

• Status: Completed
• Conditions: Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia
• Intervention / Treatment: Device: Hybrid Fractional Laser

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33173
      • Miamim Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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
  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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Arm; Subjects will be treated with hybrid fractional laser	Device: Hybrid Fractional Laser; Hybrid Fractional Laser
PLACEBO_COMPARATOR: Control Arm	Device: Hybrid Fractional Laser; Hybrid Fractional Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Vaginal health index score (VHIS)	Scores vaginal health by scoring it from 1(none) - 5(excellent).	6 months
Change from baseline in Female sexual function index questionnaire (FSFI)	Scoring 0(minimum) - 5(maximum)	6 months
Change from baseline in day-to-day impact of vaginal aging questionnaire	Questionnaire	6 months
Change from baseline in histology	Histology	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in photography	Photography	6 months

Collaborators and Investigators

• Sponsor: Sciton

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2018
• Primary Completion (ACTUAL): June 15, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (ACTUAL): August 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathological Conditions, Anatomical; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Atrophy; Dyspareunia
• Other Study ID Numbers: DIVA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes