Clobetasol, mometasone and tacrolimus therapy in the treatment of vulval lichen sclerosus in the pediatric population.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Uniwersytet Medyczny W Lublinie

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

29 Dec 2025 → ongoing

Decision date (initial)

2025-04-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Medical Research Agency, 1A Stanisława Moniuszki Street, 00-014 Warszawa

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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.

Conditions and MedDRA coding

Patients with clinically diagnosed lichen sclerosus of the vulva.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age from 2 to 18 years old.
2. 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).
3. Ability and willingness to comply with the requirements of the study protocol.
4. A confirmed clinical diagnosis of vulval lichen sclerosus.
5. No contraindications to the use of any components of the study preparations.
6. Good general condition based on physical examination.
7. Achievement of not less than 1 point on the Sn-LTS scale.
8. Normal levels of ACTH (corticotropin) hormone and cortisol.
9. 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 8

1. Topical treatment of the vulvar area with preparations containing corticosteroids or immunomodulatory drugs within 4 weeks before the randomization visit.
2. Systemic treatment with preparations containing corticosteroids or immunomodulatory drugs within 4 weeks before the randomization visit (W1).
3. Chronic infections and lesions of the vulva or vagina, other than lichen sclerosus.
4. Congenital or acquired immunodeficiency.
5. Pregnancy or lactation.
6. Known hypersensitivity to, any of the preparations used in the study.
7. Known psoriasis of the skin.
8. Other disqualifying criteria in the researcher opinion.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. Determining the safety of treatment for arms I, II and III.

Secondary endpoints 3

1. 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.
2. 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.
3. Assessment of the impact of demographic, immunological, microbiota and selected gene expression factors on the effectiveness of treatment for regimens I, II and III.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Uniwersytet Medyczny W Lublinie

Sponsor organisation

Uniwersytet Medyczny W Lublinie

Address

Ul. Aleje Raclawickie 1

City

Lublin

Postcode

20-059

Country

Poland

Scientific contact point

Organisation

Uniwersytet Medyczny W Lublinie

Contact name

Anna Torres

Public contact point

Organisation

Uniwersytet Medyczny W Lublinie

Contact name

Anna Kubiak

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications