N/A
N=12
The CO2RE® System for Vulvar Lichen Sclerosus
Vulvar Lichen Sclerosus
Bottom Line
View on ClinicalTrials.gov: NCT04148651 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators — 1.85; 0.65; 0.65; 0.73 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The CO2RE® System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Candela Corporation
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators |
1.85; 0.65; 0.65; 0.73 | — |
| 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 |
2.18; 1.10; 1.04; 1.08 | — |
| SECONDARY Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment |
4.06; 4.53 | — |
| SECONDARY Subject Satisfaction At the 12-Month Follow-up |
8 | — |
| SECONDARY Treatment Associated Pain Score |
2.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04148651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.