Lichen sclerosus vulvare MedDRA version: 20.0 Level: PT Classification code 10024434 Term: Lichen sclerosus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: DIPROSALIC - 0.05% + 3% UNGUENTO TUBO 30 G
Product Name: DIPROSALIC 0.05% + 3% UNGUENTO
Pharmaceutical Form: Ointment
INN or Proposed INN: BETAMETASONE DIPROPIONATO
Current Sponsor code: N
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. ;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. ;Timepoint(s) of evaluation of this end point: At first visit and after 4 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;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 | — |
Countries
Italy
Contacts
Public ContactU.O. OSTETRICIA E GINECOLOGIA II
U.O. OSTETRICIA E GINECOLOGIA II
Outcome results
None listed