The CO2RE® System for Vulvar Lichen Sclerosus

NCT04148651 | Completed Results FDA Device

• 1 other identifier: DHF25211
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Vulvar Lichen Sclerosus

Keywords

vulvar dystrophy; vulvar atrophy; persistent itching; leukoplakia; hyperkeratosis; sexual function

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment

  Baseline and 3 months and 6 months after the final treatment

• Subject Satisfaction At the 12-Month Follow-up

  12 months after the final treatment

• Treatment Associated Pain Score

  Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline

Study Arms (1)

CO2RE® Treatment

EXPERIMENTAL

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

Device: The CO2RE® System

Interventions

The CO2RE® System DEVICE

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).

CO2RE® Treatment

Eligibility Criteria

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

You may qualify if:

• Able to read, understand and sign informed consent for study participation;
• Female subjects with age 18-80 years;
• Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
• 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;
• Topical corticosteroid treatment, if any, will be continued during the study period;
• Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);
• One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;
• No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.

You may not qualify if:

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

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (4)

Total Dermatology Care Center

Jacksonville, Florida, 32204, United States

Location

Center for Modern Aesthetic Medicine

Jacksonville, Florida, 32207, United States

Location

HERmd (formerly Somi Javaid M.D. & Associates)

Cincinnati, Ohio, 45249, United States

Location

Lumina Med Spa

South Burlington, Vermont, 05403, United States

Location

Related Publications (5)

• 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.

  PMID: 29095746 BACKGROUND

• 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. doi: 10.1080/009262300278597.

  PMID: 10782451 BACKGROUND

• 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.

  PMID: 22594865 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

• Stewart K, Javaid S, Schallen KP, Bartlett S, Carlson NA. Fractional CO2 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.

  PMID: 34541702 RESULT

MeSH Terms

Conditions

Vulvar Lichen Sclerosus; Leukoplakia; Keratoderma, Palmoplantar, Epidermolytic

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Keratoderma, Palmoplantar, Diffuse; Keratoderma, Palmoplantar; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Small sample size of subjects enrolled and analyzed due to delayed start at one clinical site and COVID-19 pandemic.

Results Point of Contact

• Title: Medical Director
• Organization: Candela Corporation

konikap@candelamedical.com

+1 949.599.7657

Study Officials

• Konika P Schallen, MD

  Candela Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 1, 2019
• Study Start: July 11, 2018
• Primary Completion: July 30, 2020
• Study Completion: December 17, 2020
• Last Updated: March 22, 2022
• Results First Posted: January 22, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)