The CO2RE® System for Vulvar Lichen Sclerosus

Overview

Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.

Full Title of Study: “Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 3, 2020

Detailed Description

This study is a prospective, non-randomized, single-group assignment, interventional clinical trial. Female subjects with vulvar lichen sclerosus (VLS) supported by histologic findings on biopsy and/or clinical signs on physical examination and recalcitrant to mid- to high-potency steroid therapy, will undergo up to 5 monthly treatments to the vulva with a fractional CO2 laser. Investigators will assess clinical signs and architectural changes associated with VLS. Baseline measurements will be compared to follow-up at 6 weeks, 3 months, 6 months and 12 months after the final treatment. Subjects will self report sexual function using a validated FSFI Questionnaire at baseline and at the 3- and 6-month follow-ups.

Interventions

  • Device: The CO2RE® System
    • The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of leukoplakia (vulvar dystrophies).

Arms, Groups and Cohorts

  • Experimental: CO2RE® Treatment
    • All eligible subjects will undergo up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser.

Clinical Trial Outcome Measures

Primary Measures

  • Average Scores for Clinical Signs Present at Baseline as Assessed by the Investigators
    • Time Frame: Baseline and 3 , 6 and 12 months after the final treatment
    • The clinical signs of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) were each separately assessed by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and at the follow-up visits. The scores of all clinical signs present at baseline were then averaged at each follow-up visit to report a total score for change in clinical signs. This total score was compared to the baseline total score. A lower score than at baseline indicated improvement.
  • Average Scores for Architectural Changes Present at Baseline as Assessed by the Investigators
    • Time Frame: Baseline, 3 , 6 and 12 months after the final treatment
    • The architectural changes of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) were each separately assessed by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and at the follow-up visits. The scores of all architectural changes present at baseline were then averaged at each follow-up visit to report a total score that was compared to the baseline total score. A lower score than at baseline indicated improvement.

Secondary Measures

  • Change From Baseline in The Mean Female Sexual Function Index (FSFI) Score at Follow-up Visits
    • Time Frame: 3 months and 6 months after the final treatment
    • The validated Female Sexual Function Index (FSFI) was used to compare sexual function to baseline. FSFI score, a 19-item validated questionnaire assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain, in addition to providing an overall score regarding sexual function. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire, with a maximum score 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional). Subjects completed the FSFI questionnaire at baseline or before first treatment, and at the 3- and 6-month follow-up visits. The mean change in total FSFI score compared to baseline was calculated. A positive change (above 0 points) indicates improvement in sexual function.
  • Subject Satisfaction
    • Time Frame: 3, 6 and 12 months after the final treatment
    • Evaluate Subject satisfaction at 3, 6 and 12 months post-last treatment visit, using a satisfaction scale [(-2) Very dissatisfied, (-1) Dissatisfied, (0) Uncertain, (1) Satisfied, (2) Very satisfied]. The analysis quantify the percentage of Subject satisfaction (score 1 or 2)
  • Treatment Associated Pain Score
    • Time Frame: Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline
    • Subjects underwent 3-5 monthly treatments and reported discomfort associated with treatment on a 10-cm visual analogue scale (VAS) of 0 = no pain to 10 = worst possible pain, immediately after each treatment. The outcome presented here is the mean grade of discomfort/pain associated with all treatments. Lower value presents lower treatment-associated discomfort. Since patients received 3-5 monthly treatments these values were collected at each treatment over a period of 2 to 4 months for each patient.

Participating in This Clinical Trial

Inclusion Criteria

1. Able to read, understand and sign informed consent for study participation; 2. Female subjects with age 18-80 years; 3. Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination; 4. Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy; 5. Topical corticosteroid treatment, if any, will be continued during the study period; 6. Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study); 7. One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function; 8. No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam. Exclusion Criteria:

1. Presence of clinically atypical appearing nevi in the area to be treated; 2. Unexplained vaginal bleeding; 3. Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas); 4. History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant; 5. Pelvic organ prolapse > stage 2; 6. Pregnancy or planning pregnancy during the study; 7. Systemic treatment with immuno-modulatory drugs. 8. Use of vaginal dilators during study.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Candela Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Konika P Schallen, MD, Study Director, Candela Corporation

References

Sheinis M, Selk A. Development of the Adult Vulvar Lichen Sclerosus Severity Scale-A Delphi Consensus Exercise for Item Generation. J Low Genit Tract Dis. 2018 Jan;22(1):66-73. doi: 10.1097/LGT.0000000000000361.

Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208.

Thorstensen KA, Birenbaum DL. Recognition and management of vulvar dermatologic conditions: lichen sclerosus, lichen planus, and lichen simplex chronicus. J Midwifery Womens Health. 2012 May-Jun;57(3):260-75. doi: 10.1111/j.1542-2011.2012.00175.x. Review.

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.

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