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Trial record 10 of 25 for:    "Lichen Sclerosus"

Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus

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ClinicalTrials.gov Identifier: NCT03063684
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Hadassah Medical Organization

Brief Summary:
The study will examine the effects of fractional/pixel CO2 laser treatment in vaginal atrophy and in vulvar lichen sclerosus by means of histological and immuno-histochemical characterization of the epithelial layers and markers of tissue aging. The tissue characterization will be performed by biopsies of the vaginal or vulvar tissue at three different points of time: prior to treatment, two weeks after the third and last treatment, and one year after the last treatment.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Lichen Sclerosus Device: Fractional / Pixel CO2 Laser Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : April 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaginal atrophy

With decreasing estrogen levels occurring following menopause, changes of the vaginal mucosa appear: it becomes thin and pale and loses its elasticity. The blood supply decreases, normal secretion is reduced, the epithelial cells do not undergo the normal differentiation process, the bacterial population changes with loss of lactobacilli and pH increases. These changes are associated with morphological and histological changes, manifested, among other findings, by alterations in the collagen composition, loss of the trabecular organization of collagen and reduced amount of elastic fibers. Women with reduced vaginal estrogen content may report dryness, itching, discomfort, burning sensation during micturition, pain and dyspareunia. These changes are reversible: topical or systemic estrogen change the vaginal mucosa's characteristics and may also alleviate complaints arising from estrogen deficiency.

The intervention is 3 treatments with fractional / Pixel CO2 Laser

Device: Fractional / Pixel CO2 Laser

The laser energy is transferred in a fractioned manner: the laser beam splits while passing through a lens to 81 dots (9 x 9 pixels) onto approximately 1 cm2, so the laser rays hit the tissue in small spots.

For gynecological applications, the treatment is performed by a transducer, which was specifically designed for vaginal application.


Experimental: Lichen sclerosus

Lichen sclerosus is a chronic cutaneous disease involving the vulvar and peri-anal skin. The involved skin becomes thin and white, with frequently present bruises or petechiae and anatomic changes.

Lichen sclerosus is thought to be an auto-immune disorder and its most frequent signs are itching, irritation or burning. The discoloration may involve the entire vulvar and peri-anal area (sometimes having the form of an "8" or a "keyhole" surrounding the vulva and anus) or appear as separated spots of various sizes occupying only part of the skin. At advanced stages of lichen sclerosus, scarring may appear, with loss of the labia minor and adhesions which may entirely cover the clitoris.

The treatment is of topical steroid. Lichen sclerosus is a chronic disorder, and even with good treatment, in a certain proportion of cases the skin does not return to its original appearance.

The intervention is 3 treatments with fractional / Pixel CO2 Laser

Device: Fractional / Pixel CO2 Laser

The laser energy is transferred in a fractioned manner: the laser beam splits while passing through a lens to 81 dots (9 x 9 pixels) onto approximately 1 cm2, so the laser rays hit the tissue in small spots.

For gynecological applications, the treatment is performed by a transducer, which was specifically designed for vaginal application.





Primary Outcome Measures :
  1. Change from baseline of vaginal health index score [ Time Frame: T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months ]
    Score of 1-15, which includes the following parameters: elasticity, fluid volume, pH, epithelial integrity, moisture.


Secondary Outcome Measures :
  1. Change from baseline of Maturation Index [ Time Frame: T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months ]
    Ratio of parabasal cells, intermediate cells and mature squamous cells

  2. Change from baseline of pH measurement [ Time Frame: T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months ]
  3. Change from baseline of patient's symptoms [ Time Frame: T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months ]
    Visual analogue scale of symptoms (dryness, itch, irritation, pain, dysuria and dyspareunia)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Vaginal Atrophy - Inclusion Criteria

  • Menopause for more than one year
  • One or more of the following symptoms: sensation of dryness, itch, irritation, burning, discomfort, dysuria, dyspareunia
  • Characteristic atrophic changes on gynecological examination
  • Laboratory workup: pH >4.5, characteristic microscopic smear (increased number of para-basal cells)
  • Normal Pap-smear within 12 months
  • Negative vaginal culture for fungi or relevant bacteria
  • Negative test for STD pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas)

Exclusion Criteria

  • Genital skin disease
  • Active infection
  • Pelvic organs prolapse above grade 2
  • Previous surgery for pelvic organs prolapse
  • Use of systemic or local hormonal preparations during 6 months preceding the study treatment
  • History of malignant diseases
  • Undiagnosed vaginal bleeding
  • Use of analgesics or antidepressants
  • Use of anticoagulants

Lichen Sclerosus Inclusion Criteria

  • Age 18-80
  • Biopsy demonstrates characteristic changes for lichen sclerosus
  • One or more of the following symptoms: sensation of dryness, itch, irritation, burning, discomfort.
  • Characteristic changes for lichen sclerosus on gynecological examination
  • Negative vaginal culture for fungi or relevant bacteria
  • Negative test for STD pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas)

Exclusion Criteria

  • Use of steroid-containing creams for the vulvar region two months preceding recruitment
  • Additional genital skin disease
  • Active infection
  • History of malignant diseases
  • Use of analgesics or antidepressants
  • Use of anticoagulants
  • Pregnancy or planning pregnancy during the study
  • Systemic treatment with immuno-modulatory drugs

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): NCT03063684


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization

Publications:
Bachmann GA, Notelovitz M, Kelly SJ, et al: Long-term nonhormonal treatment of vaginal dryness. Clin Pract Sex 8:8, 1992

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Responsible Party: Ahinoam Lev-Sagie, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03063684     History of Changes
Other Study ID Numbers: 0598-16-HMO
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 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: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lichen Sclerosus et Atrophicus
Atrophy
Pathological Conditions, Anatomical
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases