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Phase I Number of patients achieving IGA of 0 or 1 with a ≥2 point improvement in Phase IIa |
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study |
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Female or male, age ≥ 20 years old |
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Subjects whose body mass index (BMI) at screening is within a range of ≥ 18.5 kg/m2 |
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and <30.0 kg/m2 |
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Subject's medical history shows no contraindication to the test medications |
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BMI = Body Weight (kg) / [Height (m) × Height (m)]2 |
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Subjects judged to be in good health by the investigator based upon the results of |
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Subjects did not take any of the following medications in the specified durations |
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physical examinations (PEs), electrocardiogram (ECG) test, and all items of routine |
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laboratory tests, including serum biochemistry, hematology and urinalysis, are within |
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normal range as judged by the site. Assessment items of blood biochemistry include |
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albumin, total protein, total bilirubin, ALP, SGOT, SGPT, BUN, serum creatinine |
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Assessment items of hematology tests include RBC count, WBC with differential counts |
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Phase IIa |
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hemoglobin, hematocrit and platelet count. Assessment items of urinalysis include pH |
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color, appearance, gravity, erythrocyte, leukocyte, glucose, protein, ketones and |
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nitrite |
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Female subjects show negative pregnancy test results and all male and female subjects |
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with child-bearing potential (between puberty and 2 years after menopause) should use |
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at least any one of the appropriate contraception methods as shown in inclusion |
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criteria #12 of phase IIa prior to the first study dose |
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Exposure of test sites to topical medications within 14 days prior to the |
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application of IPs |
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Any systemically-absorbed medication (excluding vitamins, food supplements, and |
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hormone contraceptives for birth control) within 14 days prior to the first dose |
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of the study |
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Any enzyme inducer/inhibitor and/or known hepatic or renal clearance-altering |
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agents within 30 days prior to the first dose of the study |
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Subjects are willing to comply with protocol-stated requirements, instructions and |
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restrictions, followed by understanding and signing the written informed consent form |
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Placement of an intrauterine device (IUD) or intrauterine system (IUS) |
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Female or male, age ≥ 20 years old |
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Patients who are diagnosed of atopic dermatitis based on the Hanifin and Rajka |
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Criteria |
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Patients with IGA score between mild (2) to moderate (3) and the Eczema Area and |
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Severity Indices (EASI) are ≤ 20 |
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Patients who have body surface area of atopic dermatitis involvement ≥ 2%, ≤ 20% |
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Patients who agree discontinuation of all treatment modalities, such as topical |
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antihistamines, topical antimicrobials, topical corticosteroid and light treatments |
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during the study period for/on the affected site(s) (except the rescue medication |
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prescribed by the study Investigator(s)) |
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Patients who agree discontinuation of systemic corticosteroids, systemic |
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antihistamines, and systemic immune modulating agents during the study period (except |
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the standard medication oral antihistamine levocetirizine and rescue medication |
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prescribed by the study Investigator(s)) |
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Patients are required to stop using treatment drugs listed in criteria #5 for at least |
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days (or longer if the treatment half-life requires so; 7 half-life should have |
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elapsed) and treatment drugs listed in criteria #6 for 28 days before the first |
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investigational drug dose administration |
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Subject is judged to be in general good health (without clinically significant |
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abnormalities) by the Investigator based on medical history, PEs, ECG, and routine |
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laboratory tests at screening |
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Patients who stopped immunosuppressant drugs for at least 28 days prior to the first |
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dosing |
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Patients who have taken oral antihistamine of levocetirizine 5 mg once daily for at |
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least 7 days before initiating the study treatment |
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Patients who are eligible and able to participate in the study and accept to enter the |
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study by signing written informed consent forms |
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All male patients and female patients with child-bearing potential (between puberty |
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and 2 years after menopause) should use at least any one of the appropriate |
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contraception methods shown below, for during and at least 4 weeks after GM-XANTHO |
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treatment |
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Total abstinence [when this is in line with the preferred and usual lifestyle of |
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the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal |
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post-ovulation methods) and withdrawal are not acceptable methods of |
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contraception] |
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Female sterilization (have had surgical bilateral oophorectomy with or without |
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hysterectomy) or tubal ligation at least six weeks before taking study treatment |
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In case of oophorectomy alone, only when the reproductive status of the woman has |
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been confirmed by follow up hormone level assessment |
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Male sterilization. For female subjects on the study, the vasectomized male |
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partner should be the sole partner for that subject |
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Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or |
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d.2+d.3) |
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Use of oral, injected or implanted hormonal methods of contraception or |
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other forms of hormonal contraception that have comparable efficacy (failure |
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rate <1%), for example hormone vaginal ring or transdermal hormone |
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contraception |
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Barrier methods of contraception: Condom or Occlusive cap (diaphragm or |
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cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal |
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suppository |
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Phase I
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presence of open sores
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obvious differences in skin color between applications sites
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excessive hair
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scar tissue tattoo
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coloration
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Subjects who have been tested positive for the following tests
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Human immunodeficiency virus (HIV)
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Hepatitis B virus (HBV): HBsAg and anti-HBc
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Hepatitis C virus (HCV)
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Phase IIa
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Patients who have active infection on the atopic dermatitis site(s) at baseline
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Patients who have known hypersensitivity to the study medication
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Patients with chronic condition(s) which either is not stable or not well controlled
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Patients having positive results for HBV, HCV or HIV screens
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Patients who are pregnant or breast feeding
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Subjects with the following conditions at the application site(s) that would interfere
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with the IP administration, skin assessment, or reaction to IPs
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Subjects with any properly diagnosed disease within 30 days prior to the first dose of
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the study
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Subjects with any diagnosed dermatological or allergic diseases within 180 days prior
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to the first study dose
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Subjects with any clinically significant hematological, endocrine, cardiovascular
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hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any
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predisposing condition that might interfere with the absorption, distribution
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metabolism and excretion of drugs
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Subjects had participated in investigational drug trials and took any investigational
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drug within 60 days prior to the first study dose
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Subjects had blood donation for more than 250 mL within 60 days or 500 mL within 90
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days prior to the first study dose
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Subjects had a history of drug abuse or alcohol abuse according to the Diagnostic and
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Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria
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Subjects cannot stop smoking and caffeine-intakes for 48 hours prior to the first
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study dose and during the entire study period, and 48 hours after the last dose
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administration of IPs
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Subjects who are inappropriate to participate in this study, as judged by the clinical
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Investigator
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Patients had participated in investigational drug trials and took any investigational
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drugs within 30 days or within 5 half-lives of the investigational drugs prior to the
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screening visit
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Patients who have any concurrent skin condition that will interfere with assessment of
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treatment
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Patients who are inevitable to engage activities involving excessive or prolonged
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exposure to sunlight
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Patients carry history of malignancy of any organ system (other than cervical
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carcinoma in situ or localized prostate cancer) within 5 years prior to study entry
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Patients who are not suitable to participate in the trial as judged by the
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Investigator(s)
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