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Randomized, Controlled Trial With Hybrid Fractional Laser

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ClinicalTrials.gov Identifier: NCT03647189
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sciton

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 10, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from baseline in Vaginal health index score (VHIS) [ Time Frame: 6 months ]
    Scores vaginal health by scoring it from 1(none) - 5(excellent).

  2. Change from baseline in Female sexual function index questionnaire (FSFI) [ Time Frame: 6 months ]
    Scoring 0(minimum) - 5(maximum)

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

  4. Change from baseline in histology [ Time Frame: 3 months ]
    Histology


Secondary Outcome Measures :
  1. Change from baseline in photography [ Time Frame: 6 months ]
    Photography



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647189


Contacts
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Contact: Sciton Inc 6504939155 jay.patel@sciton.com

Locations
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United States, Florida
Miamim Dermatology Recruiting
Miami, Florida, United States, 33173
Sponsors and Collaborators
Sciton

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Responsible Party: Sciton
ClinicalTrials.gov Identifier: NCT03647189     History of Changes
Other Study ID Numbers: DIVA-001
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Atrophy
Dyspareunia
Pathological Conditions, Anatomical
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders