Lichen simplex chronicus (LSC), also called neruodermatitis. MedDRA version: 8.1 Level: LLT Classification code 10057292 Term: Lichen simplex chronicus
Conditions
Interventions
Product Name: ASF-1075 cream 2.5%
Product Code: ASF-1075 cream 2.5%
Pharmaceutical Form: Cream
INN or Proposed INN: Oxaprozin monoethanolamine
Current Sponsor code: ASF-1075
Other descriptive name: 4,
Sponsors
Astion Danmark A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the treatment effect of ASF-1075 cream 2.5% and 5% on reducing patient assessed pruritus (VAS) in patients suffering from lichen simplex chronicus of the anogenital region following 3 weeks double-blind, vehicle-controlled treatment with a twice daily application.;Secondary Objective: The secondary objectives are to investigate the treatment effect of ASF-1075 cream 2.5% and 5% with regard to: - Patient assessed pruritus (verbal rating scale) - Clinical scores of erythema, lichenification, excoriation assessed by the investigator - General improvement of LSC assessed by the investigator - Global improvement of pruritus assessed by the patient - Patient assessed quality of life: DLQI - To assess the safety profile in the ASF-1075 cream 2.5% and 5% groups;Primary end point(s): Pruritus after 3 weeks treatment compared to baseline. At the 3 weeks visit to the clinic, the patient will rate his/her pruritus over the last 24 hours using a 100 mm visual analogue scale (VAS). | — |
Countries
Denmark
Outcome results
None listed