| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Lichen sclerosus vulvare |
| Lichen sclerosus |
|
| E.1.1.1 | Medical condition in easily understood language |
| Lichen sclerosus vulvare |
| Lichen sclerosus vulvare |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10024434 |
| E.1.2 | Term | Lichen sclerosus |
| E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
7) Main objective
Primary objective include clinical evaluation of an Investigator Global Assessment (IGA) of the severity of the disease, before and after 4 months of treatment, in two groups of patients treated with different topical medications, and comparison of the improvement in both groups of patients.
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| Obiettivo primario: I) miglioramento dei segni clinici valutati mediante esame obiettivo |
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| E.2.2 | Secondary objectives of the trial |
8) Secondary objectives
- To evaluate the change from baseline in pruritus and burning/pain as assessed by patients, and the comparison of the improvement in both groups of patients.
- To assess female sexual function and quality of life in patients at baseline and after treatment, and comparison of results in both groups of patients.
- Safety assessment of both medications.
|
Obiettivi secondari: I) valutazione soggettiva del bruciore e del prurito vulvare da parte delle pazienti nei due bracci di trattamento, mediante le scale VAS-BR e VAS-PR;
II) confronto del punteggio di questionari validati di valutazione della qualit¿ di vita e della funzione sessuale (SF-36 e FSFI) compilati dalle pazienti al momento dell¿arruolamento e al termine dei 4 mesi di terapia.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
o Female, 18 years or older, menopausal ascertained (amenorrea for 1 year or more)
o A diagnosis of biopsy proven vulvar lichen sclerosus.
o Signed written informed consent.
o Willingness and ability to comply with the study requirements.
o IGA at baseline =1
o Subjects must have = 4 or greater (on a 0 to 10 point scale) on at least one of the two visual analog scales (pruritus or pain/burning).
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- pazienti di sesso femminile adulte (>18 anni) in menopausa accertata (amenorrea da almeno 1 anno);
- diagnosi istologica di LS vulvare, in accordo alle caratteristiche istologiche descritte in letteratura
- firma di un consenso informato in cui saranno spiegate la natura della patologia e le due possibilità di trattamento, e di cui sarà data copia alla paziente;
- disponibilità al follow up
- Presenza di segni clinici e sintomi di malattia
|
|
| E.4 | Principal exclusion criteria |
o Who have received systemic immunosuppressants (e.g. corticosteroids) or hormonal therapies within 6 months prior to participation in the study.
o Who have been treated with topical therapy (e.g., topical corticosteroids, pimecrolimus, and tacrolimus) at the affected area within 6 months prior to participation in the study.
o Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease, as known data or previous
o Who have a history of lymphoma or lympadenopathy
o Who have active vulvar herpes, molluscum, or condyloma or systemic or generalized infections (bacterial, viral or fungal). Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva.
o Menstruating females of childbearing age
o Who had received an investigational drug within 6 months prior to the study or who intend to use other investigational drugs during the course of this study.
o Who are hypersensitive to clobetasol propionate 0.05% or betamethasone dipropionate 0.05% plus salicilic acid 3% or any of the components of the creams.
o Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study, as reported in RCP.
o Who have a history of substance abuse or any factor, which limits the subject’s ability to cooperate with the study procedures.
o Who are uncooperative, known to miss appointments (according to subjects’ records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.
o Who are treated, as reported in RCP |
- trattamento sistemico con corticosteroidi, retinoidi o terapia ormonale sostitutiva e estro-progestinici durante i sei mesi precedenti all’arruolamento;
- trattamento con terapie topiche (per esempio corticosteroidi, immunosoppressori, terapie ormonali) sull’area genitale nei sei mesi precedenti l’arruolamento nello studio;
- intolleranza o ipersensibilità ad ogni componente dei due farmaci utilizzati;
- stati di immunocompromissione noti o pregressi (per es. AIDS, sindrome di Wiskott-Aldrich, neoplasie maligne)
- anamnesi positiva per linfoma, linfoadenopatie;
- Infezioni vulvari o sistemiche attive, dermatiti, lesioni pre-neoplastiche (neoplasia intra-epiteliale vulvare –VIN-, neoplasia intra-epiteliale vaginale –VaIN-) o carcinoma della vulva o della vagina;
- Donne in età fertile
- Persone che hanno assunto un farmaco sperimentale nei 6 mesi precedenti lo studio o intendono usarne uno durante lo studio.
- Persone ipersensibili o allergiche al clobetasolo propionato 0,05% o al betametasone dipropionato (0.05%) e acido salicilico (3%) o qualsiasi componente dei due farmaci
- Pazienti con patologie mediche severe che possono controindicare la partecipazione allo studio, come da RCP dei due farmaci
- Storia di abuso di sostanze che potrebbero limitare la capacità della paziente di adempiere alle procedure dello studio o la compliance al follow up
- Pazienti che non sono disponibili al follow up
- Pazienti in trattamento con terapie farmacologiche, come da RCP dei due farmaci
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary End Point is to evaluate the efficacy of both treatments in reducing signs and symptoms of lichen sclerosus as clinically assessed by the study investigators.
The main measure for the clinical evaluation is a score of 0 to 3 (no clinical sign, and mild, moderate, or severe clinical signs) given to each participant by the study investigator.
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| efficacia del trattamento valutata mediante esame obiettivo. I segni clinici verranno misurati con un punteggio che va da 0 a 3 (nessun segno clinico, lieve, moderato, grave) al momento dell’arruolamento ed al termine del quarto mese di trattamento. Verrà infatti applicata la scala IGA (“Investigator Global Assessment”), già validata in altri studi per lo score (da 0 a 3) di gravità della patologia. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| At first visit and after 4 months of treatment |
| Al basale e dopo 4 mesi di trattamento |
|
| E.5.2 | Secondary end point(s) |
| To evaluate the change in burning/pain and pruritus as assessed by patients, respectively using VAS-BR and VAS-PR scales, at baseline visit and after 4 months of therapy, and to compare the improvement in both groups of patients. VAS scale both for burning and for pruritus employ a 0-to-10 score of gravity of symptoms (0= no burning/no pruritus; 10= maximum grade of burning/pruritus); To assess female sexual function and quality of life in patients at baseline and after for months of treatment, using SF36 and FSFI scales, and comparison of results in both groups of patients.; analysis of patients' histologic examination and epidemiological data.; Safety assessment of both medications. If side effects occur, diagnosis will be made by principal investigator, who will collect any data related to possible complications and patient's clinical conditions. |
| confronto del miglioramento soggettivo del bruciore e del prurito da parte delle pazienti, rispettivamente mediante l¿utilizzo delle scale VAS-BR e VAS-PR, al momento dell¿arruolamento ed al termine del quarto mese di trattamento. La scala VAS per il bruciore e quella per il prurito utilizzano uno score di gravit¿ dei sintomi da 0 a 10 (0= nessun bruciore/prurito; 10=massimo bruciore/prurito).; confronto del miglioramento nel punteggio dei questionari di valutazione della qualit¿ di vita e della funzione sessuale (SF36 e FSFI), compilati dalle pazienti al momento dell¿arruolamento ed al termine del quarto mese di terapia nei due bracci di trattamento.; l¿analisi dei referti dell¿esame istologico delle pazienti, e l¿analisi dei dati epidemiologici delle pazienti.; eventuali effetti collaterali al trattamento. Nel caso in cui si verifichi una complicanza, la diagnosi verr¿ fatta dallo Sperimentatore responsabile, e verranno raccolti dati circa il decorso delle complicanze e le condizioni cliniche del paziente. |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| At first visit and after 4 months of treatment; At first visit and after 4 months of treatment; Al basale; At first visit and after 4 months of treatment |
| Al basale e dopo 4 mesi di trattamento; Al basale e dopo 4 mesi di trattamento; Al basale; Al basale e dopo 4 mesi di trattamento |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.5.1 | Number of sites anticipated in the EEA | 1 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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