Prurigo can present either with hyperkeratotic nodules as prurigo nodularis or without nodules as Prurigo simplex. The disease is characterised by intensely pruritic, lichenified, or excoriated papules and nodules. A hallmark symptom is chronic pruritus, often associated with a high impact on quality of life. MedDRA version: 16.0 Level: LLT Classification code 10037084 Term: Prurigo nodularis System Organ Class: 100000004858
Conditions
Interventions
Product Name: aprepitant gel
Pharmaceutical Form: Gel
INN or Proposed INN: Aprepitant
CAS Number: 170729-80-3
Current Sponsor code: LP0066
Other descriptive name: APREPITANT
Concentration unit: mg/g m
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed informed consent has been obtained -Patient with Prurigo suffering from chronic pruritus. -Disease duration > six month -Patients with symmetrical prurigo lesions at upper extremities (both arms) or lower extremities (both legs) -Pruritus VAS greater than 6/10 two days before Visit 1 (Screening). -Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressant, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation. -Patients need to agree to apply the IMP in accordance with the study protocol. An emollient cream (DAC Basiscreme) serves as rescue medication, which can be applied as often as desired at all body areas. -Adult male or female patients, aged 18 to 80 years. -Patients will be recruited from inpatient clinic as well as from outpatient clinic. 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Concomitant medications that are primarily metabolized through CYP3A4 - Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial. - UV-irradiation during the last 6 weeks prior to the Visit 1 (Screening). - Prescribed systemic medications like antihistamines, antidepressants, antipsychotics, corticosteroids are allowed if: a. medication was taken at least 4 weeks prior to the trial and b. no changes were made concerning the intake or dosage during the last 4 weeks and during the course of the trial. - Clinically significant abnormalities in Blood analyses - Marked hair density that will interfere with the absorption of IMP in treated areas - Anamnestic excessive use of alcohol or tobacco or drugs - Presence of active tumor disease or history of malignancies within five years prior to Visit 1 other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer. - Known or suspected hypersensitivity to component(s) of investigational products. - Within the last 30 days or current participation in any other interventional clinical trial - Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month. - Previously enrolled/randomised in this clinical trial. - In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state). - Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding. - Females of child-bearing potential with positive pregnancy test. - Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of topical treatment with aprepitant on pruritus compared to placebo, after 4 weeks of treatment;Secondary Objective: - efficacy of topical applied aprepitant on the status of the skin condition - long-term effect (e.g., duration of action, duration of reduction of pruritus) - safety of topical administration of aprepitant - levels of substance P in the serum of patients at Screening - effect of topical applied aprepitant on skin structures - expression of the NK1 receptor, the cellular composition and structure and global gene expression - evaluation of skin biopsies for expression of additional targets - systemic exposure of aprepitant after topical administration ;Primary end point(s): Pruritus ;Timepoint(s) of evaluation of this end point: Pruritus at end of treatment by VAS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pruritus at Visits 2, 3 and 5. Patient’s assessment of skin condition at each visit and at end of treatment Clinical Score at each visit and at end of treatment TEWL at Visit 2, 3, 4 and at end of treatment Mexameter at Visit 2, 3, 4 and at end of treatment Volumetric imaging (in Patients with Prurigo nodularis) at Visit 2, 3, 4 and at end of treatment ;Timepoint(s) of evaluation of this end point: Pruritus at Visits 2, 3 and 5. Patient’s assessment of skin condition at each visit and at end of treatment by treatment area. Clinical Score at each visit and at end of treatment TEWL at Visit 2, 3, 4 and at end of treatment Mexameter at Visit 2, 3, 4 and at end of treatment Volumetric imaging (in Patients with Prurigo nodularis) at Visit 2, 3, 4 and at end of treatment | — |
Countries
Germany
Contacts
Public ContactPrincipal investigator, Prof. Metz
Charité-Department of Dermatology
Outcome results
None listed