Patients with clinically diagnosed lichen sclerosus of the vulva.
Conditions
Brief summary
Evaluation of treatment efficacy, assessed as the percentage of patients with significant clinical improvement after 12 weeks, defined as achieving a minimum 75% reduction in subjective and physical symptoms physical symptoms and achieving a minimum of 50% improvement in quality of life from the baseline for arms I, II and III., Determining the safety of treatment for arms I, II and III.
Detailed description
A comparison of treatment efficacy, assessed as the percentage of patients with complete remission after 12 weeks, defined as the complete absence of subjective and physical symptoms vs. to baseline between arms I, II and III., Comparison of the effectiveness of maintaining the treatment effect assessed as a percentage of patients with a significant one clinical improvement 15 months after starting treatment, defined as maintaining 75% reduction of signs and symptoms and improvement of quality of life in relation to values initial between arms I, II and III., Assessment of the impact of demographic, immunological, microbiota and selected gene expression factors on the effectiveness of treatment for regimens I, II and III.
Interventions
Sponsors
Uniwersytet Medyczny W Lublinie
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of treatment efficacy, assessed as the percentage of patients with significant clinical improvement after 12 weeks, defined as achieving a minimum 75% reduction in subjective and physical symptoms physical symptoms and achieving a minimum of 50% improvement in quality of life from the baseline for arms I, II and III., Determining the safety of treatment for arms I, II and III. | — |
Secondary
| Measure | Time frame |
|---|---|
| A comparison of treatment efficacy, assessed as the percentage of patients with complete remission after 12 weeks, defined as the complete absence of subjective and physical symptoms vs. to baseline between arms I, II and III., Comparison of the effectiveness of maintaining the treatment effect assessed as a percentage of patients with a significant one clinical improvement 15 months after starting treatment, defined as maintaining 75% reduction of signs and symptoms and improvement of quality of life in relation to values initial between arms I, II and III., Assessment of the impact of demographic, immunological, microbiota and selected gene expression factors on the effectiveness of treatment for regimens I, II and III. | — |
Countries
Poland
Outcome results
None listed