A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO ASSESS THE ANTI-INFLAMMATORY PROPERTIES OF TOPICAL CRX-197 IN LESIONAL SKIN OF ADULT SUBJECTS WITH MILD TO MODERATE ATOPIC DERMATITIS
- Conditions
- mild to moderate atopic dermatitis
- Registration Number
- EUCTR2008-002284-13-DE
- Lead Sponsor
- CombinatoRx, Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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 <13
•Difference in ADSI lesional score between lesions treated in the same subject should not be greater than 1
?I04 TEWL in the lesional areas at least 12 g/m2h
?I05 Subject must be free from a condition/disease that the investigator feels will interfere with the interpretation of the study results.
?I06 Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
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) no
F.1.3.1 Number of subjects for this age range
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
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