Trial Outcomes & Findings for Laser Treatment for Vulvar Lichen Sclerosus (NCT NCT04134494)

Last Updated: 2024-06-05

Results Overview

The baseline depth of lichen sclerosus will be based on the results of the clinical biopsy performed before study participation. The investigators will use the study biopsy collected at the follow-up visit three months after the last treatment to determine resolution of disease or, if disease persists, to what depth. The biopsies will therefore serve as an objective means to determine effective treatment of disease.

Recruitment status

TERMINATED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

From enrollment to 3 months after the last laser treatment

Results posted on

2024-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Overall Study Lost to Follow-up	2

Baseline Characteristics

2 patients did not have the primary outcome assessed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=13 Participants Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Age, Categorical <=18 years	0 Participants n=93 Participants • 2 patients did not have the primary outcome assessed
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants • 2 patients did not have the primary outcome assessed
Age, Categorical >=65 years	4 Participants n=93 Participants • 2 patients did not have the primary outcome assessed
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	13 participants n=93 Participants
Baseline depth of lichen penetration	600 Microns n=93 Participants

PRIMARY outcome

Timeframe: From enrollment to 3 months after the last laser treatment

Population: Enrolled participants who had a post treatment biopsy

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants The ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA) delivered laser energy in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment was be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment	0 microns Interval -100.0 to 300.0

SECONDARY outcome

Timeframe: From enrollment to 3 months after last laser treatment

The VSQ is a 21-item written questionnaire with four scales: symptoms, emotions, life-impact, and sexual impact. Each item is assessed with yes or no questions. If a participant answers no, they receive a score of 0, and if the participant answers yes, they receive a score of 1 for each question. The results are added to a composite score. Minimum score (better outcome): 0 Maximum score (worse outcome): 21

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants The ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA) delivered laser energy in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment was be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Change in Symptoms and Quality of Life Using the Vulvovaginal Symptom Questionnaire (VSQ)	-3 score on a scale Interval -4.0 to 0.0

SECONDARY outcome

Timeframe: 3 months after last laser treatment

The PGIC is a written questionnaire to assess change in status or symptoms over time. Patients can say that their symptoms are: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6) or very much worse (7). Minimum score (better outcome): 1 Maximum score (worse outcome): 7

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants The ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA) delivered laser energy in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment was be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Change in Symptoms Using the Patient Global Impression Scale of Change (PGIC)	3 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: From enrollment to 3 months after last laser treatment

The PGIs is a written questionnaire to assess current status or symptoms. Patients can say that their symptoms are: normal (1), mild (2), moderate (3), or severe (4). Minimum score (better outcome): 1 Maximum score (worse outcome): 4

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants The ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA) delivered laser energy in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment was be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Change in Symptom Severity Using the Patient Global Impression Scale of Severity (PGIS)	0 score on a scale Interval -1.0 to 0.0

SECONDARY outcome

Timeframe: 3 months after last laser treatment

Using a written questionnaire, patients will be asked how satisfied they were with the treatment. They can choose that they are extremely satisfied (1), somewhat satisfied (2), neither satisfied nor dissatisfied (3), somewhat dissatisfied (4), or extremely dissatisfied (5). Minimum score (better outcome): 1 Maximum score (worse outcome): 5

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants The ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA) delivered laser energy in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment was be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Satisfaction With Treatment Using a Participant Satisfaction Questionnaire	2 score on a scale Interval 2.0 to 3.0

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=13 participants at risk Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
Reproductive system and breast disorders Light spotting	0.00% 0/13 • Baseline to six months Light spotting (bleeding from the area outside the vagina where the laser is used) Allergic reaction to topical anesthetic (numbing cream) Infection from the biopsy or the laser treatment
Skin and subcutaneous tissue disorders Allergic reaction to topical anesthetic	0.00% 0/13 • Baseline to six months Light spotting (bleeding from the area outside the vagina where the laser is used) Allergic reaction to topical anesthetic (numbing cream) Infection from the biopsy or the laser treatment
Infections and infestations Infection from the biopsy or the laser treatment	0.00% 0/13 • Baseline to six months Light spotting (bleeding from the area outside the vagina where the laser is used) Allergic reaction to topical anesthetic (numbing cream) Infection from the biopsy or the laser treatment

Additional Information

Roger Lefevre

BIDMC

Phone: 6176674070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place