Randomized, Controlled Trial With Hybrid Fractional Laser

NCT03647189 | Completed FDA Device

• 1 other identifier: DIVA-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Change from baseline in photography

  6 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Subjects will be treated with hybrid fractional laser

Device: Hybrid Fractional Laser

Control Arm

PLACEBO COMPARATOR

Device: Hybrid Fractional Laser

Interventions

Hybrid Fractional Laser DEVICE

Hybrid Fractional Laser

Control Arm; Treatment Arm

Eligibility Criteria

• Age: 40 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Healthy biological female aged between 40 to 70 years 2. Is post-menopausal with a AND b OR c:
• No menses for at least 12 months
• Follicle-stimulating hormone (FSH) level over 40mlU/mL
• 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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• Vaginal irritation in the absence of infection
• Chronic burning sensation
• Chronic itching in the absence of infection
• Recurring urinary tract infections (UTIs)
• Vaginal dryness during sexual activity
• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Sciton: lead

Study Sites (1)

Miamim Dermatology

Miami, Florida, 33173, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: August 10, 2018
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)