mild to moderate atopic dermatitis
Conditions
Interventions
Product Name: CRx-197 topical cream
Pharmaceutical Form: Cream
INN or Proposed INN: loratadine
Concentration unit: % percent
Concentration type: equal
Concentration number: 0,3-
INN or Proposed INN: n
Sponsors
CombinatoRx, Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, candidates must meet the following inclusion criteria: ? I01 Subject must voluntarily give written informed consent ? I02 Subject must be 18 to 60 years of age ? I03 Subject must manifest mild to moderate AD diagnosed according to Hanifin and Rajka [Hanifin, 1980] • Two Lesional areas of 20-50 cm2 ? ADSI lesional score =4 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from study entry if any of the following exclusion criteria exist at the time of enrolment or after obtaining Screening laboratories: Medical History: ? E01 Acne, suntan, dermatitis, hyper- or hypopigmentation other than atopic dermatitis, or tattoos in the treatment areas that would prevent ready assessment of skin reaction ? E02 Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease ? E03 Mania or acute delirium or epilepsy ? E04 Narrow angle glaucoma ? E05 Hyperthyroidism by medical history, TSH less than the LLN, or subject receiving any thyroid medication ? E06 Diabetes (both insulin and non-insulin dependent) ? E07 Liver disease - ALT laboratory value that exceeds 1.5x ULN ? E08 Visible Bacterial, viral or fungal skin infections (at the test areas); or inflammatory dermatoses (at the test areas); or facial rosacea ? E9 Known allergic reactions or hypersensitivity to any of the components of the study preparations ? E10 Known severe kidney disease, acute urinary retention, prostatic hypertrophy with post-void residual urine or laboratory value of creatinine that exceeds 1.5x ULN ? E11 Significant gastrointestinal diseases including but not limited to pyloric stenosis or paralytic ileus ? E12 Active varicella, tuberculosis, syphilis or post-vaccine reactions ? E13 Autoimmune disease (e.g. lupus erythematosis) ? E14 Ultraviolet (UV) therapy or significant UV exposure in the four weeks before treatment application or for the duration of the study ? E15 History of malignancy (except for treated or excised basal cell carcinoma) ? E16 History of drug or alcohol abuse (as defined by the Investigator) ? E17 Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study ? E18 Subject with demonstrated hypokalemia (less than LLN) Infection History: ? E19 Positive for HIV antibody ? E20 Positive for hepatitis B surface antigen (HBbsAg) ? E21 Positive for hepatitis C (HCV) Treatment History: ? E22 Subjects who require medications that inhibit the cytochrome P450 (CYP450) 2D6 pathway such as: • Quinidine • Cimetidine • Type 1 anti-arrhythmics • Phenothiazines • Selective serotonin reuptake inhibitors such as fluoxetine, paroxetine, or sertraline • Reserpine, other anticholinergic drugs, or sympathomimetic drugs ? E23 Systemic treatment or locally acting medication which might counter or influence the study aim (e.g. immunomodulators azothioprine or cyclosporine, corticosteroids or medications that influence liver function) in the four weeks prior to first study treatment (exception: corticosteroid inhalation for asthma will be allowed at a dose not exceeding 1 mg/day) ? E24 Systemic treatments in the four weeks prior to treatment application that may interact with any of the study drugs, such as: • MAO inhibitors • Anti-depressants • Anti-seizure medications • Anti-psychotics • Anti-histamines • Anti-coagulants • Anti-mycotics Miscellaneous: ? E25 Treatment received with any investigational agent within one month before this trial. ? E26 Female subject who is pregnant or lactating or with a positive pregnancy test ? E27 Topical cosmetic preparations are allowed on skin areas other than the test areas, but must not be changed during the study ? E28 Sunbathing and solarium use are not allowed during the study. If bathing and showering, the subject mus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the effectiveness, tolerability and safety of CRx-197 in subjects with mild to moderate AD.;Secondary Objective: ;Primary end point(s): Exploratory Efficacy Endpoints: • Differences in change from Baseline to Days 8, 15, 22 and 29, 36 and 43 in erythema measured by chromametry between the treatments within each cohort separately • Difference in change from Baseline to Days 8, 15, 22, 29, 36 and 43 in ADSI between the treatments within each cohort separately • Differences in change from Baseline to Days 8, 15, 22 and 29, 36 and 43 in TEWL between treatments within each cohort separately Safety Endpoints: • Safety and tolerability as assessed by treatment emergent adverse events (AEs), concomitant medications, change from baseline in physical exam, vital signs, laboratory values •Difference in change from Baseline to Days 8, 15, 22, 29, 36 and 43 in skin thickness measured by ultrasound at between the treatments within each cohort separately PK Exploratory Analysis: • PK assessment of plasma levels at the Baseline Visit (prior to treatment), Day 22 and Day 43 | — |
Countries
Germany
Outcome results
None listed