Trial Outcomes & Findings for Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus (NCT NCT02573883)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

52 participants

Primary outcome timeframe

Change from baseline score to score at six months

Results posted on

2021-10-12

Participant Flow

Patients were recruited from urogynecologic and gynecology academic center office visits with vulvar biopsy-proven lichen sclerosus. Patients underwent block randomization with a 1:1 ratios, with stratification for participants based on prior clobetasol use. Participates stayed in randomized group until six months when they had the option to crossover into other treatment group and receive that treatment or continue to 12 months with current treatment.

Participant milestones

Participant milestones
Measure	Clobetasol Propionate- No Crossover Clobetasol Propionate 0.05% ointment 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 then as need. Participants did not cross over.	Fractionated Carbon Dioxide Laser- No Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then no further treatment.	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need.
Six Month Follow Up STARTED	25	27	0	0
Six Month Follow Up COMPLETED	24	27	0	0
Six Month Follow Up NOT COMPLETED	1	0	0	0
One Year Follow Up STARTED	13	17	11	10
One Year Follow Up COMPLETED	11	16	11	10
One Year Follow Up NOT COMPLETED	2	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Clobetasol Propionate- No Crossover Clobetasol Propionate 0.05% ointment 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 then as need. Participants did not cross over.	Fractionated Carbon Dioxide Laser- No Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then no further treatment.	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need.
Six Month Follow Up Lost to Follow-up	1	0	0	0
One Year Follow Up Lost to Follow-up	2	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fractionated Carbon Dioxide Laser n=27 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=25 Participants Clobetasol Propionate 0.05% ointment 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	Total n=52 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 11 • n=5 Participants	61.5 years STANDARD_DEVIATION 8.9 • n=7 Participants	64.5 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	25 participants n=7 Participants	52 participants n=5 Participants
Prior Clobetasol Exposure	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline score to score at six months

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).

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=27 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=24 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change in SkinDEX-29 Score	-16.83 score on a scale Standard Deviation 18.09	-5.92 score on a scale Standard Deviation 5.81	—	—

SECONDARY outcome

Timeframe: Baseline to six months

Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus. VSQ is a 21-item instrument and scores range from 0 to 20 with increased scores indicating increased vulvovaginal symptom bother. The change in VSQ is reported with more negative scores indicating greater improvement.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=27 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=24 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)	-3.92 score on a scale Standard Deviation 4.12	-0.58 score on a scale Standard Deviation 5.11	—	—

SECONDARY outcome

Timeframe: Six month to one year after treatment

Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus. VSQ is a 21-item instrument and scores range from 0 to 20 with increased scores indicating increased vulvovaginal symptom bother. The change in VSQ is reported with more negative scores indicating greater improvement.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=16 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=11 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover n=11 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover n=10 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ)	0.44 score on a scale Standard Deviation 4.43	0.3 score on a scale Standard Deviation 2.41	-1.82 score on a scale Standard Deviation 3.66	-2.9 score on a scale Standard Deviation 3.98

SECONDARY outcome

Timeframe: Six months from treatment

Patient global impression of satisfaction total score on visual analog scale (very satisfied or satisfied) ranging from 1-5 with higher scores indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=27 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=24 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score	21 Participants	9 Participants	—	—

SECONDARY outcome

Timeframe: 1 year from treatment

Patient global impression of satisfaction total score on visual analog scale (very satisfied or satisfied) ranging from 1-5 with higher scores indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=16 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=11 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover n=11 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover n=10 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score	14 Participants	4 Participants	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline to 6 months after treatment

The Vaginal Health Index is a five item scale with scores ranging from 5-25 with lower scores indicating greater urogenital atrophy. The change in VHI is express with more negative scores indicating greater improvement between study time points.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=27 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=24 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change Vaginal Health Index (VHI) Score	1.92 score on a scale Standard Deviation 4.34	-0.43 score on a scale Standard Deviation 3.62	—	—

SECONDARY outcome

Timeframe: Six month to one year after treatment

The Vaginal Health Index is a five item scale with scores ranging from 5-25 with lower scores indicating greater urogenital atrophy. The change in VHI is express with more negative scores indicating greater improvement between study time points.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=16 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=11 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover n=11 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover n=10 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change Vaginal Health Index (VHI) Score	-2.86 score on a scale Standard Deviation 4.37	1.44 score on a scale Standard Deviation 4.45	1.73 score on a scale Standard Deviation 2.83	1.3 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline to 6 months after treatment

Patient subjective scale of symptoms of Lichen Sclerosus. Each item scaled 0-10 with greater severity of symptoms indicated by higher score. Results expressed as change with more negative values indicating greater improvement.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=27 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=24 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change Vulvar Symptom Visual Analog Scale (VAS) Score Itching	-3.26 score on a scale Standard Deviation 3.75	-1.83 score on a scale Standard Deviation 2.75	—	—
Change Vulvar Symptom Visual Analog Scale (VAS) Score Burning	-2.78 score on a scale Standard Deviation 3.76	-1.00 score on a scale Standard Deviation 3.21	—	—
Change Vulvar Symptom Visual Analog Scale (VAS) Score Irritation	-4.15 score on a scale Standard Deviation 4.04	-1.32 score on a scale Standard Deviation 2.84	—	—
Change Vulvar Symptom Visual Analog Scale (VAS) Score Pain with sex	-0.69 score on a scale Standard Deviation 2.95	-0.14 score on a scale Standard Deviation 1.35	—	—
Change Vulvar Symptom Visual Analog Scale (VAS) Score Tearing of vulvar skin	-1.77 score on a scale Standard Deviation 3.55	-1.32 score on a scale Standard Deviation 4.07	—	—
Change Vulvar Symptom Visual Analog Scale (VAS) Score Dysuria	-2.11 score on a scale Standard Deviation 3.47	-0.78 score on a scale Standard Deviation 2.37	—	—
Change Vulvar Symptom Visual Analog Scale (VAS) Score Pain defecation	-1.11 score on a scale Standard Deviation 2.83	-0.78 score on a scale Standard Deviation 2.67	—	—

SECONDARY outcome

Timeframe: Six months to one year after treatment

Patient subjective scale of symptoms of Lichen Sclerosus. Each item scaled 0-10 with greater severity of symptoms indicated by higher score. Results expressed as change with more negative values indicating greater improvement in symptoms (better outcome).

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=16 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=11 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover n=11 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover n=10 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change Vulvar Symptom Visual Analog Scale (VAS) Score Burning	-0.73 score on a scale Standard Deviation 3.43	-1.5 score on a scale Standard Deviation 3.87	-0.73 score on a scale Standard Deviation 4.45	-0.9 score on a scale Standard Deviation 2.6
Change Vulvar Symptom Visual Analog Scale (VAS) Score Irritation or tearing	-0.38 score on a scale Standard Deviation 4.03	-1 score on a scale Standard Deviation 3.54	-1.64 score on a scale Standard Deviation 2.69	0.67 score on a scale Standard Deviation 3.71
Change Vulvar Symptom Visual Analog Scale (VAS) Score Pain with sex	-1.12 score on a scale Standard Deviation 4.26	0 score on a scale Standard Deviation 0	-1.62 score on a scale Standard Deviation 3.25	-2 score on a scale Standard Deviation 4
Change Vulvar Symptom Visual Analog Scale (VAS) Score Tearing of vulvar skin	-0.14 score on a scale Standard Deviation 3.8	-0.8 score on a scale Standard Deviation 2.66	-2.12 score on a scale Standard Deviation 3.14	-0.22 score on a scale Standard Deviation 1.99
Change Vulvar Symptom Visual Analog Scale (VAS) Score Dysuria	-0.5 score on a scale Standard Deviation 4.77	-0.2 score on a scale Standard Deviation 3.97	-1.27 score on a scale Standard Deviation 2.94	-0.4 score on a scale Standard Deviation 0.84
Change Vulvar Symptom Visual Analog Scale (VAS) Score Painful defecation	0 score on a scale Standard Deviation 3.21	-0.57 score on a scale Standard Deviation 3.98	-0.09 score on a scale Standard Deviation 1.38	-0.89 score on a scale Standard Deviation 1.36
Change Vulvar Symptom Visual Analog Scale (VAS) Score Itching	-0.8 score on a scale Standard Deviation 3.76	-0.1 score on a scale Standard Deviation 3.03	-1.82 score on a scale Standard Deviation 3.06	0.89 score on a scale Standard Deviation 4.76

SECONDARY outcome

Timeframe: Six months to one year from treatment

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.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=16 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=11 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover n=11 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover n=10 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change SkinDEX-29 Score	-0.78 score on a scale Standard Deviation 25.94	-7.05 score on a scale Standard Deviation 22.13	-10.23 score on a scale Standard Deviation 17.53	-1.52 score on a scale Standard Deviation 11

SECONDARY outcome

Timeframe: Baseline to Six months from treatment

Provider scored objective appearance of vulvar Lichen Sclerosus. Each item scaled 0-10 with greater severity of appearance indicated by higher score. Results expressed as change with more negative values indicating greater improvement.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=27 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=24 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change Objective Provider VAS Visual Analog Scale White Plaque	-1.81 score on a scale Standard Deviation 1.70	-1.3 score on a scale Standard Deviation 1.96	—	—
Change Objective Provider VAS Visual Analog Scale Cigarette Paper	-2.58 score on a scale Standard Deviation 1.92	-1.5 score on a scale Standard Deviation 1.9	—	—
Change Objective Provider VAS Visual Analog Scale Introital Narrowing	-1.73 score on a scale Standard Deviation 2.82	-0.70 score on a scale Standard Deviation 2.16	—	—
Change Objective Provider VAS Visual Analog Scale Perianal Involvement	-0.73 score on a scale Standard Deviation 3.49	-1.77 score on a scale Standard Deviation 3.35	—	—
Change Objective Provider VAS Visual Analog Scale Loss of Labial Minora	-0.96 score on a scale Standard Deviation 2.44	-0.78 score on a scale Standard Deviation 2.26	—	—
Change Objective Provider VAS Visual Analog Scale Fusion of Labia Minora	-0.5 score on a scale Standard Deviation 2.5	0.35 score on a scale Standard Deviation 2.92	—	—
Change Objective Provider VAS Visual Analog Scale Phimosis	-1.28 score on a scale Standard Deviation 2.3	0.22 score on a scale Standard Deviation 2.04	—	—
Change Objective Provider VAS Visual Analog Scale Fissure	-2.12 score on a scale Standard Deviation 2.4	-1.78 score on a scale Standard Deviation 2.41	—	—
Change Objective Provider VAS Visual Analog Scale Erosion	-2.08 score on a scale Standard Deviation 2.86	-0.57 score on a scale Standard Deviation 1.88	—	—

SECONDARY outcome

Timeframe: Six months to One Year from treatment

Provider scored objective appearance of vulvar Lichen Sclerosus. Each item scaled 0-10 with greater severity of appearance indicated by higher score. Results expressed as change with more negative values indicating greater improvement.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=16 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=11 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover n=11 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover n=10 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Change Objective Provider VAS Visual Analog Scale White Plaque	-0.71 score on a scale Standard Deviation 3.29	-1.25 score on a scale Standard Deviation 1.49	-0.27 score on a scale Standard Deviation 2.24	-0.22 score on a scale Standard Deviation 1.45
Change Objective Provider VAS Visual Analog Scale Cigarette Paper	0.07 score on a scale Standard Deviation 3.1	0.38 score on a scale Standard Deviation 1.6	-0.45 score on a scale Standard Deviation 1.81	-0.2 score on a scale Standard Deviation 1.48
Change Objective Provider VAS Visual Analog Scale Introital Narrowing	0 score on a scale Standard Deviation 2.6	0.88 score on a scale Standard Deviation 2.53	-0.18 score on a scale Standard Deviation 0.52	-0.1 score on a scale Standard Deviation 2.42
Change Objective Provider VAS Visual Analog Scale Perianal Involvement	-0.77 score on a scale Standard Deviation 4.07	0.29 score on a scale Standard Deviation 1.7	0.64 score on a scale Standard Deviation 4.7	-1.4 score on a scale Standard Deviation 1.9
Change Objective Provider VAS Visual Analog Scale Loss of Labial Minora	0.5 score on a scale Standard Deviation 2.9	-0.5 score on a scale Standard Deviation 1.69	0.73 score on a scale Standard Deviation 2.8	1.2 score on a scale Standard Deviation 2.9
Change Objective Provider VAS Visual Analog Scale Fusion of Labia Minora	0.14 score on a scale Standard Deviation 2.54	-0.25 score on a scale Standard Deviation 1.91	-1.09 score on a scale Standard Deviation 2.59	-1 score on a scale Standard Deviation 2.83
Change Objective Provider VAS Visual Analog Scale Phimosis	1.43 score on a scale Standard Deviation 2.21	-0.5 score on a scale Standard Deviation 1.69	-0.18 score on a scale Standard Deviation 1.66	0.2 score on a scale Standard Deviation 2.53
Change Objective Provider VAS Visual Analog Scale Fissure	0.07 score on a scale Standard Deviation 2.53	0.62 score on a scale Standard Deviation 1.06	-0.45 score on a scale Standard Deviation 2.62	-1.4 score on a scale Standard Deviation 2.32
Change Objective Provider VAS Visual Analog Scale Erosion	1 score on a scale Standard Deviation 2.8	0.12 score on a scale Standard Deviation 0.35	-0.36 score on a scale Standard Deviation 1.03	-0.6 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Six Month to One Year from treatment

Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=16 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=11 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover n=11 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover n=10 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Number of Patients With Adverse Outcomes	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 Weeks to Six months from treatment

Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment.

Outcome measures

Outcome measures
Measure	Fractionated Carbon Dioxide Laser n=27 Participants Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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.	Clobetasol Propionate n=24 Participants Clobetasol Propionate 0.05% ointment 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	Clobetasol Propionate to Laser Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Clobetasol Propionate 0.05% ointment 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 then as need. Participants choose to crossover to Fractionated Carbon Dioxide Laser at six months because symptoms had not resolved. Fractionated Carbon Dioxide Laser: 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.	Fractionated Carbon Dioxide Laser to Clobetasol Crossover Patients with biopsy proven lichen sclerosus previously treated with clobetasol propionate Fractionated Carbon Dioxide Laser: 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. Then patients choose to crossover to the Clobetasol Propionate Treatment at six months due to continued symptoms. Clobetasol Propionate 0.05% ointment 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 then as need
Number of Patients With Adverse Outcomes	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 12 Weeks from treatment

Population: Please see adverse events section for description of adverse events.

Total number for adverse outcomes (of any severity) to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment.