Efficacy and safety of ASF-1075 cream 2.5% and 5% on pruritus in patients with lichen simplex chronicus (neurodermatitis) of the anogenital region.A phase II, multi-centre, double-blind, vehicle-controlled, parallel group, proof of concept study.
- Conditions
- ichen simplex chronicus (LSC), also called neruodermatitis.MedDRA version: 8.1Level: LLTClassification code 10057292Term: Lichen simplex chronicus
- Registration Number
- EUCTR2006-005221-37-DK
- Lead Sponsor
- Astion Danmark A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
a) Patients of either gender aged from 18 to 75 years
b) A clinical diagnosis of genital/anal LSC with a medical history of at least 6 months
c) Pruritus (overall pruritus over the last 24 hours) rated at the baseline visit as moderate intensity, i.e. at least 30 mm using the 100 mm VAS
d) Females of childbearing potential should either be clinically sterile (postmenopausal 12 months, hysterectomy or tubal ligation) or use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with spermicid, intrauterine device (IUD), condom with intravaginal spermicid.
e) willing and able to comply to the study procedures
f) signed Informed Consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
a) Differential diagnosis such as hemorrhoids, psoriasis, lichen planus, lichen sclerosus et atrophicus, radiation related sequelae, any malignancies of the anogenital area (Bowen’s disease, Paget’s disease) and known active contact dermatitis in the treatment area (irritant, allergy). Patient suffering from any known genital infection.
b) Patient with lumbosacral radiculopathy
c) Active skin disease other than LSC, e.g. psoriasis, which in the opinion of the investigator will interfere with evaluation of efficacy or safety or another progressive or serious disease that may interfere with the study outcome, specifically:
•HIV
•Severe hepatic disease
•Severe renal disease
d) Concomitant treatment with corticosteroids (local during the last 2 weeks or systemic during the last 4 weeks), topical capsaicin or thalidomide during the last 4 weeks
e) Patients who have received UV therapy during the last 4 weeks
f) Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before study start and during the study;
g) Physical examination with disease findings considered to the discretion of the investigator to be relevant to the outcome of the study;
h) Known allergic reactions to components of the study preparations or to NSAIDS;
i) Other systemic medications which may interfere with the evaluation of anti pruritic effect, or which may influence the severity of disease: antihistamines, corticosteroids, retinoids, anti-malaria, anti psychotic, tricyclic antidepressants, or benzodiazepines and any other NSAI drug or aspirin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method