Trial Outcomes & Findings for The CO2RE® System for Vulvar Lichen Sclerosus (NCT NCT04148651)

Last Updated: 2022-03-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

At Baseline, 3, 6 and 12 months after the final treatment

Results posted on

2022-03-22

Participant Flow

Although 14 subjects enrolled, 1 subject was withdrawn from the study due to a protocol violation and 1 subject was found to be not eligible prior to her first treatment. Therefore, 12 subjects are included in this analysis.

Unit of analysis: Treated areas

Participant milestones

Participant milestones
Measure	CO2RE® Treatment All eligible subjects underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained protocol regimen. 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).
Overall Study STARTED	12 12
Overall Study COMPLETED	10 10
Overall Study NOT COMPLETED	2 2

Reasons for withdrawal

Reasons for withdrawal
Measure	CO2RE® Treatment All eligible subjects underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained protocol regimen. 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).
Overall Study Lost to Follow-up	2

Baseline Characteristics

The CO2RE® System for Vulvar Lichen Sclerosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CO2RE® Treatment n=12 Participants All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen. 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 treatment of leukoplakia (vulvar dystrophies).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	56.6 Years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
FSFI	13.9 score on a scale STANDARD_DEVIATION 10.1 • n=5 Participants

PRIMARY outcome

Timeframe: At Baseline, 3, 6 and 12 months after the final treatment

Population: At Baseline, 12 subjects had 96 clinical signs present (score \>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at 3- and 6-month follow-up visits 11 subjects were assessed (with 89 clinical signs averaged for each visit) and at the 12-month follow-up visit 10 subjects were assessed (with 79 clinical signs averaged).

Outcome measures

Outcome measures
Measure	CO2RE® Treatment n=96 Clinical signs All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen. 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).
Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators Average score of clinical signs at Baseline	1.85 score on a scale Standard Deviation 0.73
Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators Average score of clinical signs at 3-months follow-up visit	0.65 score on a scale Standard Deviation 0.74
Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators Average score of clinical signs at 6-months follow-up visit	0.65 score on a scale Standard Deviation 0.76
Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators Average score of clinical signs at 12-months follow-up visits	0.73 score on a scale Standard Deviation 0.83

PRIMARY outcome

Timeframe: Baseline, 3 , 6 and 12 months after the final treatment

Population: At Baseline, 12 patients had 55 architectural changes present (score \>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at the 3- and 6-month follow-ups, 11 subjects were assessed (with 51 architectural changes averaged for each visit) and at the 12-month follow-up 10 subjects were assessed (with 49 architectural changes averaged).

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.

Outcome measures

Outcome measures
Measure	CO2RE® Treatment n=55 Architectural Changes All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen. 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).
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 Average score of architectural changes at Baseline	2.18 score on a scale Standard Deviation 0.72
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 Average score of architectural changes at 3-month follow-up	1.10 score on a scale Standard Deviation 0.90
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 Average score of architectural changes at 6-month follow-up	1.04 score on a scale Standard Deviation 0.87
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 Average score of architectural changes at 12-month follow-up	1.08 score on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline and 3 months and 6 months after the final treatment

Population: At Baseline, 12 patients completed FSFI questionnaires. At the 3-month visit, 11 subjects completed the FSFI (one subject missed the visit). At the 6-month follow-up, 12 subjects completed the FSFI (one subject missed her visit but provided her self-assessments remotely).

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.

Outcome measures

Outcome measures
Measure	CO2RE® Treatment n=12 Participants All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen. 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).
Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment Mean Change in FSFI At the 3-Month Follow-up	4.06 units on a scale Standard Error 2.25
Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment Mean Change in FSFI At the 6-Month Follow-up	4.53 units on a scale Standard Error 2.41

SECONDARY outcome

Timeframe: 12 months after the final treatment

Population: Two subjects missed the 12-month follow-up. Therefore, subject assessments were reported for 10 subjects 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.

Outcome measures

Outcome measures
Measure	CO2RE® Treatment n=10 Participants All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen. 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).
Subject Satisfaction At the 12-Month Follow-up	8 Participants

SECONDARY outcome

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

Population: A total of 57 sessions were conducted (10 subjects had 5 treatments,1 subject had 4 treatments and 1 subject had 3 treatments)

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.

Outcome measures

Outcome measures
Measure	CO2RE® Treatment n=57 Number of Treatments All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen. 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).
Treatment Associated Pain Score	2.6 score on a scale Standard Deviation 2.5

Adverse Events

Subjects Treated With CO2RE® Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

Candela Corporation

Phone: +1 949.599.7657

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place