Randomized, Controlled Trial With Hybrid Fractional Laser

• Sponsor: Sciton (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03647189
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia	Device: Hybrid Fractional Laser	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Controlled Trial With Hybrid Fractional Laser for Vulvovaginal Atrophy in Breast Cancer Survivors and Menopausal Females
• Actual Study Start Date: Aug 10, 2018
• Actual Primary Completion Date: Jun 15, 2021
• Actual Study Completion Date: Jun 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline in Vaginal health index score (VHIS) [6 months]

   Scores vaginal health by scoring it from 1(none) - 5(excellent).

2. Change from baseline in Female sexual function index questionnaire (FSFI) [6 months]

   Scoring 0(minimum) - 5(maximum)

3. Change from baseline in day-to-day impact of vaginal aging questionnaire [6 months]

   Questionnaire

4. Change from baseline in histology [3 months]

   Histology

Secondary Outcome Measures

1. Change from baseline in photography [6 months]

   Photography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

4. Vaginal irritation in the absence of infection

5. Chronic burning sensation

6. Chronic itching in the absence of infection

7. Recurring urinary tract infections (UTIs)

8. Vaginal dryness during sexual activity

9. 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

1. 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
2. The investigator feels that for any reason the subject is not eligible to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miamim Dermatology	Miami	Florida	United States	33173

Sponsors and Collaborators

• Sciton

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sciton
• ClinicalTrials.gov Identifier: NCT03647189
• Other Study ID Numbers: DIVA-001
• First Posted: Aug 27, 2018
• Last Update Posted: Jun 18, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Dyspareunia; Atrophy

Study Results

No Results Posted as of Jun 18, 2021