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Sections: Correlations,
Clinical Trials, and HPO
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There is one clinical trial.
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.
Description: 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.
Measure: Change in histology and depth of disease from baseline to three months after the last laser treatment Time: From enrollment to 9 month follow up visitDescription: 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
Measure: Change in symptoms and quality of life using the Vulvovaginal Symptom Questionnaire (VSQ) Time: From enrollment to 9 month follow up visitDescription: 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
Measure: Change in symptoms using the Patient Global Impression Scale of Change (PGIC) Time: From enrollment to 9 month follow up visitDescription: 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
Measure: Change in symptom severity using the Patient Global Impression Scale of Severity (PGIS) Time: From enrollment to 9 month follow up visitDescription: Photographs will be rated by observers blinded to whether a photo is before or after treatment
Measure: Vulvar lichen sclerosus improvement as assessed using photographs Time: From enrollment to 9 month follow up visitDescription: 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
Measure: Satisfaction with treatment using a participant satisfaction questionnaire Time: From enrollment to 9 month follow up visitAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports