E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lichen simplex chronicus (LSC), also called neruodermatitis. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057292 |
E.1.2 | Term | Lichen simplex chronicus |
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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 |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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). |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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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The end of the trial is defined as the date the database is locked based on the clean file. |
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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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |