CLOBETASOL PROPIONATE for Vulval lichen sclerosus|Lichen sclerosus

Inclusion criteria

• {"criterion_text":"- Age from 2 to 18 years old."}
• {"criterion_text":"- Obtaining informed voluntary consent from the parent/legal representative for the patient's participation in the study and obtaining the patient's consent (patients who are 13 years of age or older)."}
• {"criterion_text":"- Ability and willingness to comply with the requirements of the study protocol."}
• {"criterion_text":"- A confirmed clinical diagnosis of vulval lichen sclerosus."}
• {"criterion_text":"- No contraindications to the use of any components of the study preparations."}
• {"criterion_text":"- Good general condition based on physical examination."}
• {"criterion_text":"- Achievement of not less than 1 point on the Sn-LTS scale."}
• {"criterion_text":"- Normal levels of ACTH (corticotropin) hormone and cortisol."}
• {"criterion_text":"- The patient is not in the phase of active immunization (a minimum interval of 2 weeks between immunization and taking a dose of the investigational medicinal product)."}

Exclusion criteria

• {"criterion_text":"- Topical treatment of the vulvar area with preparations containing corticosteroids or immunomodulatory drugs within 4 weeks before the randomization visit."}
• {"criterion_text":"- Systemic treatment with preparations containing corticosteroids or immunomodulatory drugs within 4 weeks before the randomization visit (W1)."}
• {"criterion_text":"- Chronic infections and lesions of the vulva or vagina, other than lichen sclerosus."}
• {"criterion_text":"- Congenital or acquired immunodeficiency."}
• {"criterion_text":"- Pregnancy or lactation."}
• {"criterion_text":"- Known hypersensitivity to, any of the preparations used in the study."}
• {"criterion_text":"- Known psoriasis of the skin."}
• {"criterion_text":"- Other disqualifying criteria in the researcher opinion."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as percentage of patients with significant clinical improvement after 12 weeks: achieving a minimum 75% reduction in subjective and physical symptoms and achieving a minimum of 50% improvement in quality of life from baseline for arms I, II and III."}
• {"endpoint_text":"- Determining the safety of treatment for arms I, II and III.","definition_or_measurement_approach":"No further definition or measurement approach provided in the source."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as percentage of patients with complete remission after 12 weeks: complete absence of subjective and physical symptoms compared to baseline between arms I, II and III."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as percentage of patients maintaining clinical improvement 15 months after starting treatment: maintenance of 75% reduction of signs and symptoms and improvement of quality of life versus baseline between arms I, II and III."}
• {"endpoint_text":"- Assessment of the impact of demographic, immunological, microbiota and selected gene expression factors on the effectiveness of treatment for regimens I, II and III.","definition_or_measurement_approach":"Assessment of associations between demographic, immunological, microbiota and selected gene expression factors and treatment effectiveness for regimens I, II and III (no further measurement detail provided)."}

Poland

Earliest CTIS Part Ii Submission Date

17-04-2025

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

299

Number Of Sites

1

Number Of Participants

93

Primary sponsor

Full Name

Uniwersytet Medyczny W Lublinie

Organisation Type

Educational Institution

Country Of Registered Address

Poland