The CO2RE® System for Vulvar Lichen Sclerosus

Vulvar Lichen Sclerosus Clinical Trial

Official title:

Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148651
• Other study ID #: DHF25211
• Status: Completed
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: December 17, 2020

Study information

• Verified date: February 2022
• Source: Candela Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 17, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Intervention

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).

Locations

Country	Name	City	State
United States	HERmd (formerly Somi Javaid M.D. & Associates)	Cincinnati	Ohio
United States	Center for Modern Aesthetic Medicine	Jacksonville	Florida
United States	Total Dermatology Care Center	Jacksonville	Florida
United States	Lumina Med Spa	South Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Candela Corporation

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Stewart K, Javaid S, Schallen KP, Bartlett S, Carlson NA. Fractional CO(2) laser treatment as adjunctive therapy to topical steroids for managing vulvar lichen sclerosus. Lasers Surg Med. 2022 Jan;54(1):138-151. doi: 10.1002/lsm.23476. Epub 2021 Sep 20. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators	Each clinical sign of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those clinical signs present at baseline (baseline score >0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows: Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of clinical signs present at baseline for each subject / Number of grades; A lower average score means better outcome.	At Baseline, 3, 6 and 12 months after the final treatment
Primary	Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators	Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those architectural changes present at baseline (baseline score >0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows: Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of architectural changes present at baseline for each subject / Number of grades; A lower average score means better outcome.	Baseline, 3 , 6 and 12 months after the final treatment
Secondary	Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment	Female Sexual Function Index (FSFI) is a validated, self-reported 19-item questionnaire that assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire, with a maximum total score possible of 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional). Change = (Follow-up score - Baseline score). Mean change was calculated for all scores at the 3- and 6-month follow-ups.	Baseline and 3 months and 6 months after the final treatment
Secondary	Subject Satisfaction At the 12-Month Follow-up	Evaluate Subject satisfaction at the 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) at the 12-month follow-up.	12 months after the final treatment
Secondary	Treatment Associated Pain Score	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.	Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline