Laser Treatment for Vulvar Lichen Sclerosus
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|ClinicalTrials.gov Identifier: NCT04134494|
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : November 10, 2020
The object of this non-randomized, prospective study is to assess the effectiveness of ablative fractional 2940 nm laser treatment of vulvar lichen sclerosus.
Aim 1: To assess physical and histological changes related to vulvar lichen sclerosus before and after laser treatment.
Aim 2: To evaluate participant satisfaction for laser treatment of vulvar lichen sclerosus.
The results of this study will determine whether fractional 2940 nm laser is an effective treatment option for lichen sclerosus, particularly for those participants not eligible for high-dose topical steroids or who have failed prior treatment with topical steroids.
|Condition or disease||Intervention/treatment||Phase|
|Vulvar Lichen Sclerosus||Device: Ablative Fractional 2940 nm Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single group of 30 patients with biopsy-proven Lichen sclerosus will be treated on a monthly basis for 3 months. Biopsy to be repeated at month #6. The biopsy from before treatment will be compared with biopsies after treatment.|
|Masking:||None (Open Label)|
|Masking Description:||No masking will be used as all patients will receive the treatment.|
|Official Title:||Effectiveness of Ablative Fractional 2940 nm Laser Treatment for Vulvar Lichen Sclerosus|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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
Device: Ablative Fractional 2940 nm Laser
- Change in histology and depth of disease from baseline to three months after the last laser treatment [ Time Frame: From enrollment to 9 month follow up visit ]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.
- Change in symptoms and quality of life using the Vulvovaginal Symptom Questionnaire (VSQ) [ Time Frame: From enrollment to 9 month follow up visit ]
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
- Change in symptoms using the Patient Global Impression Scale of Change (PGIC) [ Time Frame: From enrollment to 9 month follow up visit ]
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
- Change in symptom severity using the Patient Global Impression Scale of Severity (PGIS) [ Time Frame: From enrollment to 9 month follow up visit ]
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
- Vulvar lichen sclerosus improvement as assessed using photographs [ Time Frame: From enrollment to 9 month follow up visit ]Photographs will be rated by observers blinded to whether a photo is before or after treatment
- Satisfaction with treatment using a participant satisfaction questionnaire [ Time Frame: From enrollment to 9 month follow up visit ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134494
|Contact: Roger Lefevre, MDemail@example.com|
|Contact: Michele Hacker, MpH, ScDfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Contact: Roger Lefevre, MD email@example.com|
|Principal Investigator:||Roger Lefevre, MD||Beth Israel Deaconess Medical Center|