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

NCT03063684 | Completed

• 1 other identifier: 0598-16-HMO
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Atrophy; Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• Change from baseline of vaginal health index score

  Score of 1-15, which includes the following parameters: elasticity, fluid volume, pH, epithelial integrity, moisture.

  T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months

Secondary Outcomes (3)

• Change from baseline of Maturation Index

  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 pH measurement

  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

  T0-Recruitment, T1-2-4 weeks, T2- 6-8 weeks, T3-10-12 weeks, T4-12-14 weeks, T5- 12 months

Study Arms (2)

Vaginal atrophy

EXPERIMENTAL

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

Lichen sclerosus

EXPERIMENTAL

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

Interventions

Fractional / Pixel CO2 Laser DEVICE

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.

Lichen sclerosus; Vaginal atrophy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (7)

• Dafforn TR, Della M, Miller AD. The molecular interactions of heat shock protein 47 (Hsp47) and their implications for collagen biosynthesis. J Biol Chem. 2001 Dec 28;276(52):49310-9. doi: 10.1074/jbc.M108896200. Epub 2001 Oct 9.

  PMID: 11592970 BACKGROUND

• Capon A, Mordon S. Can thermal lasers promote skin wound healing? Am J Clin Dermatol. 2003;4(1):1-12. doi: 10.2165/00128071-200304010-00001.

  PMID: 12477368 BACKGROUND

• Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401.

  PMID: 25608269 BACKGROUND

• Perino A, Calligaro A, Forlani F, Tiberio C, Cucinella G, Svelato A, Saitta S, Calagna G. Vulvo-vaginal atrophy: a new treatment modality using thermo-ablative fractional CO2 laser. Maturitas. 2015 Mar;80(3):296-301. doi: 10.1016/j.maturitas.2014.12.006. Epub 2014 Dec 25.

  PMID: 25596815 BACKGROUND

• Gaspar A, Brandi H, Gomez V, Luque D. Efficacy of Erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause. Lasers Surg Med. 2017 Feb;49(2):160-168. doi: 10.1002/lsm.22569. Epub 2016 Aug 22.

  PMID: 27546524 BACKGROUND

• Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.

  PMID: 25333211 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 24, 2017
• Study Start: September 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: April 28, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)