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Randomized, Controlled Trial With Hybrid Fractional Laser

Primary Purpose

Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hybrid Fractional Laser

About this trial

This is an interventional treatment trial for Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Miamim Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

Subjects will be treated with hybrid fractional laser

Outcomes

Primary Outcome Measures

Change from baseline in Vaginal health index score (VHIS)

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

Change from baseline in Female sexual function index questionnaire (FSFI)

Scoring 0(minimum) - 5(maximum)

Change from baseline in day-to-day impact of vaginal aging questionnaire

Questionnaire

Change from baseline in histology

Histology

Secondary Outcome Measures

Change from baseline in photography

Photography

Full Information

NCT ID

NCT03647189

First Posted

August 23, 2018

Last Updated

June 17, 2021

Sponsor

Sciton

1. Study Identification

Unique Protocol Identification Number

NCT03647189

Brief Title

Randomized, Controlled Trial With Hybrid Fractional Laser

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

August 10, 2018 (Actual)

Primary Completion Date

June 15, 2021 (Actual)

Study Completion Date

June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sciton

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

Subjects will be treated with hybrid fractional laser

Arm Title

Control Arm

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

Hybrid Fractional Laser

Intervention Description

Hybrid Fractional Laser

Primary Outcome Measure Information:

Title

Change from baseline in Vaginal health index score (VHIS)

Description

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

Time Frame

6 months

Title

Change from baseline in Female sexual function index questionnaire (FSFI)

Description

Scoring 0(minimum) - 5(maximum)

Time Frame

6 months

Title

Change from baseline in day-to-day impact of vaginal aging questionnaire

Description

Questionnaire

Time Frame

6 months

Title

Change from baseline in histology

Description

Histology

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change from baseline in photography

Description

Photography

Time Frame

6 months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. 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 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 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

Facility Information:

Facility Name

Miamim Dermatology

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Randomized, Controlled Trial With Hybrid Fractional Laser

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