Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus

NCT02573883 | Completed Phase 3 Results DMC

• 1 other identifier: 2016-154
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to compare the effects, good and bad, of fractionated CO2 laser treatment and clobetasol propionate .05% ointment on vulvar lichen sclerosus.

Conditions

Vulvar Lichen Sclerosus

Keywords

Vulva; Lichen Sclerosus; Fractionated Carbon Dioxide Laser; Mona Lisa Laser; Clobetasol Propionate; Vulvodynia

Outcome Measures

Primary Outcomes (1)

• Change in SkinDEX-29 Score

  The Skindex-29 is a validated questionnaire for assessing acute dermatologic symptoms over a 4-week period. The Skindex-29 is a 29 question version of the original SkinDEX questionnaire. Total numeric score is reported ranging from 0-100. Scores reported as a change between six months and baseline with more negative scores indicating greater improvement in symptoms (better outcome).

  Change from baseline score to score at six months

Secondary Outcomes (14)

• Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)

  Baseline to six months

• Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)

  Six month to one year after treatment

• Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score

  Six months from treatment

• Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score

  1 year from treatment

• Change Vaginal Health Index (VHI) Score

  Baseline to 6 months after treatment

Study Arms (2)

Prior Clobetasol Exposure

EXPERIMENTAL

Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate

Device: Fractionated Carbon Dioxide Laser; Drug: Clobetasol Propionate 0.05% ointment

No Prior Clobetasol Exposure

ACTIVE COMPARATOR

Patients with biopsy proven lichen sclerosus never previously treated with clobetasol propionate.

Device: Fractionated Carbon Dioxide Laser; Drug: Clobetasol Propionate 0.05% ointment

Interventions

Fractionated Carbon Dioxide Laser DEVICE

Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart.

Also known as: SmartXide -V2-LR system, Mona Lisa Laser

No Prior Clobetasol Exposure; Prior Clobetasol Exposure

Clobetasol Propionate 0.05% ointment DRUG

Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment.

Also known as: Temovate Propionate 0.05% ointment

No Prior Clobetasol Exposure; Prior Clobetasol Exposure

Eligibility Criteria

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

You may qualify if:

• Biopsy proven symptomatic vulvar lichen sclerosus
• Ability to understand the study, accept randomization and logistically follow-up with scheduled visits
• English Speaking

You may not qualify if:

• Known vulvar malignancy
• Pregnancy or planning pregnancy or less than 3 months postpartum
• Premenopausal
• Current or prior diagnosis of any gynecologic malignancy
• Previous pelvic radiation therapy
• Allergy to topical steroid
• Active Urinary Tract Infection (UTI), vulvar infection (candida, herpes, bacterial vaginosis, trichomoniasis or other infection)
• Pelvic organ prolapse \> than Stage 2
• Treatment with systemic immunomodulators, topical calcineurin inhibitors (tacrolimus, pimecrolimus), or vaginal hormonal or vulvar topical steroid use within 2 months of enrollment
• History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)
• IUD (Intrauterine Device)
• Skindex-29 overall score \<21, below mildly impaired health related quality of life threshold

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Medstar Washington Hospital Center Lafayette Office

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (4)

• Chi CC, Kirtschig G, Baldo M, Brackenbury F, Lewis F, Wojnarowska F. Topical interventions for genital lichen sclerosus. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD008240. doi: 10.1002/14651858.CD008240.pub2.

  PMID: 22161424 BACKGROUND

• Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.

  PMID: 24605832 BACKGROUND

• He Z, Lu C, Chren MM, Zhang Z, Li Y, Ni X, Buchtel V HA, Ryan PF, Li GZ. Development and psychometric validation of the Chinese version of Skindex-29 and Skindex-16. Health Qual Life Outcomes. 2014 Dec 24;12:190. doi: 10.1186/s12955-014-0190-4.

  PMID: 25539748 BACKGROUND

• Burkett LS, Siddique M, Zeymo A, Brunn EA, Gutman RE, Park AJ, Iglesia CB. Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):968-978. doi: 10.1097/AOG.0000000000004332.

  PMID: 33957642 DERIVED

MeSH Terms

Conditions

Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus; Vulvodynia

Interventions

Clobetasol; Ointments

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

The study was unblinded for patients and evaluators and only performed at a single center. The steroid group had more non-compliant patients (25% vs 4%). We limited our investigation to only postmenopausal women Further research using placebo and sham lasers for treatment blinding is needed. Patients previously using topical vaginal estrogen were continued on prior treatment, groups were not stratified based on estrogen exposure, however there where equal numbers between groups.

Results Point of Contact

• Title: Dr. Cheryl Iglesia
• Organization: Medstar Health Research Institute

cheryl.iglesia@medstar.net

202-877-6526

Study Officials

• Cheryl Iglesia, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 12, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-10

Locations

US (1)