A phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetic properties and effectiveness after applying an investigational cream to healthy adults and atopic dermatitis patients
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0005182
- Lead Sponsor
- Avixgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
Part A (Healthy adults)
1) Healthy adults
2) Those aged 19 to 65 at the time of signing an Informed Consent Form (ICF)
3) Those who agree to participate in the clinical trial and voluntarily sign a written Informed Consent Form (ICF)
4) Subjects who are informed about the clinical trial, cooperative, and able to participate in the trial until its end date
5) Those who are deemed to have no clinically significant findings in physical examination, vital signs, laboratory testing, and electrocardiography during screening
6) Those to whom the Investigational Product (IP) can be administered
Part B (Atopic Dermatitis patients)
1) The following atopic dermatitis patients:
- Patients diagnosed to have atopic dermatitis based on the Hanifin and Rajka diagnostic criteria (i.e.,, patients who have at least three (3) of the four (4) major features accompanied by three or more minor features provided in the Hanifin and Rajka diagnostic criteria*)
- Patients with mild-to-moderate atopic dermatitis with a score of 16 or below according to the Eczema Area and Severity Index (EASI) and whose lesions are detected to involve an area equal to or greater than 5% of the entire body surface area (BSA)
2) Those aged 19 to 65 at the time of signing an Informed Consent Form (ICF)
3) Those who agree to participate in the clinical trial and voluntarily sign a written Informed Consent Form (ICF)
4) Subjects who are informed about the clinical trial, cooperative, and able to participate in the trial until its end date
5) Those who are deemed to have no clinically significant findings in physical examination, vital signs, laboratory testing, and electrocardiography during screening
Part A (Healthy adults)
1) Those who have any of the following skin diseases:
- Those with any visually confirmed skin diseases
- Those with psoriasis or active atopic dermatitis, or eczema
- Those with a medical history of atopic dermatitis
2) Those with any uncontrollable chronic diseases (e.g., chronic active hepatitis, hypertension, diabetes or the like)
3) Those with a medical history of other clinically significant or past diseases in the liver, kidney, digestive system, respiratory system, nervous system, cardiovascular system, and blood/tumor
4) Those with sitting systolic blood pressure of =150 mmHg or =90 mmHg and diastolic blood pressure of =100 mmHg or =55 mmHg during screening
5) Those with a medical history including clinically significant or serious allergy that requires acute or chronic care (e.g., seasonal, pet, environment, food allergies or the like)
6) Those who received oral steroids or oral antibiotics, systemic photochemotherapy, and other immunosuppressants within four (4) weeks prior to a screening visit
7) Those who sunbathed or received tanning bed therapy, ultraviolet B (UVB) therapy or PUVA [psoralen + ultraviolet A (UVA)] therapy within four (4) weeks prior to a screening visit
8) Those who used topical steroids or antibiotics within one (1) week prior to a screening visit
9) Those who used a topical calcineurin inhibitor (such as tacrolimus, pimecrolimus, or the like) within one (1) week prior to a screening visit
10) Those with a sunburn, tattoo, scar, hirsutism, excessive freckles or the like in the test site and its periphery
11) Those with a medical history of contact dermatitis due to contact with bandages, cosmetics, metals, or the like
12) Those with any of the following renal dysfunctions found during screening:
- Renal dysfunction defined by a value that is greater than the normal upper limit of serum creatinine
- Estimated Glomerular Filtration Rate (eGFR) of < 60 mL/min/1.73m2 calculated from Modification of Diet in Renal Disease (MDRD) equation
13) Those with a medical history of hypersensitivity reaction to ingredients of the IP and other medications (aspirin, antibiotics, or the like), or clinically significant hypersensitivity reaction
14) Those diagnosed to have an unstable coronary artery disease, angina, congestive heart failure or arrhythmia requiring active medical management within four (4) weeks prior to a screening visit
15) Those diagnosed as experiencing a myocardial infarction or acute heart failure within six (6) months prior to a screening visit
16) Those administered with an anticoagulant or an antiplatelet agent within four (4) weeks prior to a screening visit
17) Those who have a history of drug abuse within eight (8) weeks prior to a screening visit or have tested positive for drug abuse in a urine drug screening
18) Those who have received any other drug while participating in a different clinical trial (based on the date of the last dose) within six (6) months (180 days) prior to a screening visit, or are planning to participate in another clinical trial
19) Those who have received a certain prescription medication or oriental medicine within two (2) weeks prior to a screening visit, or a certain over-the-counter (OTC) drug or vitamin formulation within one (1) week prior (But if the subject satisfies the other requirements, the subject may be included in the clinical trial at the discretion of the investigator)
20) Those whose blood AST (SGOT) and ALT (SGPT) exceed
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Monitoring of adverse events such as subjective/objective symptoms, etc.;Severity evaluation of local tolerability symptoms (burning, stinging, erythema, pruritus);Analysis of Pharmacokinetics (Area under the curve from the time of dosing to the last measurable concentration, The plasma concentration reaches a maximum at a time, The elimination half-life, The maximum drug concentration in plasma);Treatment success rate verified by the Investigator’s Static Global Assessment (ISGA) for a patient with atopic dermatitis;Atopic dermatitis severity index
- Secondary Outcome Measures
Name Time Method VAS (Visual Analogue Scale)