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Clobetasol, mometasone and tacrolimus therapy in the treatment of vulval lichen sclerosus in the pediatric population.
EU CTIS ID: 2024-514003-33-00
What this study is testing
The purpose of the study is to compare the efficacy and safety of use, as well as to evaluate the impact of demographic, immunologic, microbiologic (gut and vulvar microbiota) and genetic factors on response to treatment with the following medicinal products: - Arm I - 0.05% clobetasol propionate, - Arm II - 0.1% mometasone furoate, - Arm III - 0.03% tacrolimus in the pediatric population.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age from 2 to 18 years old.
- 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).
- Ability and willingness to comply with the requirements of the study protocol.
- A confirmed clinical diagnosis of vulval lichen sclerosus.
- No contraindications to the use of any components of the study preparations.
- Good general condition based on physical examination.
You likely can't join if
- Topical treatment of the vulvar area with preparations containing corticosteroids or immunomodulatory drugs within 4 weeks before the randomization visit.
- Systemic treatment with preparations containing corticosteroids or immunomodulatory drugs within 4 weeks before the randomization visit (W1).
- Chronic infections and lesions of the vulva or vagina, other than lichen sclerosus.
- Congenital or acquired immunodeficiency.
- Pregnancy or lactation.
- Known hypersensitivity to, any of the preparations used in the study.
See the full eligibility criteria
- Age from 2 to 18 years old.
- 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).
- Ability and willingness to comply with the requirements of the study protocol.
- A confirmed clinical diagnosis of vulval lichen sclerosus.
- No contraindications to the use of any components of the study preparations.
- Good general condition based on physical examination.
- Achievement of not less than 1 point on the Sn-LTS scale.
- Normal levels of ACTH (corticotropin) hormone and cortisol.
- 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).
- Topical treatment of the vulvar area with preparations containing corticosteroids or immunomodulatory drugs within 4 weeks before the randomization visit.
- Systemic treatment with preparations containing corticosteroids or immunomodulatory drugs within 4 weeks before the randomization visit (W1).
- Chronic infections and lesions of the vulva or vagina, other than lichen sclerosus.
- Congenital or acquired immunodeficiency.
- Pregnancy or lactation.
- Known hypersensitivity to, any of the preparations used in the study.
- Known psoriasis of the skin.
- Other disqualifying criteria in the researcher opinion.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.