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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:

Many studies have been published recently describing the use of a fractional/pixel CO2 laser for the treatment of various disorders of the vulva and the vagina, such as atrophy due to estrogen deficiency, urinary stress incontinence, skin diseases (lichen sclerosus) and more.

The results of the studies that investigated this technology in relation to vaginal atrophy and urinary stress incontinence have shown improvement in symptoms after a series of only 3 treatments.

The proposed effect of the fractional CO2 laser is based on studies performed on non-genital tissues [Daffon, Capon], which demonstrated changes in the connective tissue and proliferation of fibroblasts, as well as formation of collagen and elastic fibers. The suggested explanation is based on the theory that heat shock proteins are involved in the process and arise due to thermal tissue damage, and this in turn activate tissue cytokines, growth factors and fibroblasts. These theories have not been proven for vulvar and vaginal tissues, and except for the demonstration of histologic and morphologic changes in the irradiated tissues [Salvatore, Menopause 2015], the cellular mechanism of action and the nature of the process mediating the changes in uro-genital tissues has not yet been examined.

The technology known as fractional CO2 has been used for many years in dermatology and plastic surgery. In this method, the laser beam splits while passing through a lens to 81 dots (9 x 9 pixels) onto approximately 1 cm2. The laser beam penetrates the tissue and causes minimal evaporation around each spot of the fractionated beams and release of heat only at the desired tissue depth. The method of energy transfer to tissues in tiny dots leads to the creation of various thermal effects in the focus of the beam, around the
Sponsor: Hadassah Medical Organization

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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 ]
  • 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)


Original Secondary Outcome: Same as current

Information By: Hadassah Medical Organization

Dates:
Date Received: February 18, 2017
Date Started: April 2017
Date Completion: April 2019
Last Updated: February 21, 2017
Last Verified: February 2017