NCT Number: NCT04148651
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.
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Notify Me18 year–80 year
Female
Interventional
Not applicable
Center for Modern Aesthetic Medicine, Jacksonville, Florida, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: At Baseline, 3, 6 and 12 months after the final treatment
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.
Time frame: Baseline, 3 , 6 and 12 months after the final treatment
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.
Time frame: Baseline and 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.
Time frame: 12 months after the final treatment
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.
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.
Candela Corporation
Industry
Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus
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