Atopic dermatitis
Conditions
Interventions
1:There were 2 untreated control sites and 4 test sites on each arm of each subject, and the dose of each test site of the two arms was 6uL reference preparation.
2:There were 2 untreated control sites and 4 test sites on each arm of each subject, and the dose of each test site of the two arms was 6uL reference preparation.
3:There were 2 untreated control sites and 4 test sites on each arm of each subject, and the dose of each test site of the two arms was 6uL reference preparation.
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Chinese healthy volunteers aged from 18 to 50 years old (including boundary value), both men and women; 2.The body weight of male subjects is not less than 50.0kg, and that of female subjects is not less than 45.0 kg; body mass index is in the range of 19.0-28.0kg/m2 (including boundary value). Body mass index (BMI) = weight (kg) / height (m2); 3.Subjects who showed adequate vasoconstriction with topical corticosteroids, that is, "respondent" (see soP for the criteria of "respondent"); 4.Written informed consent; 5.Voluntary obedience to the research regulations.
Exclusion criteria
Exclusion criteria: 1. People who have ever had or are currently thinking of any serious clinical disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other disease that can interfere with the test results; 2. Have a history of allergy to drugs, food or other substances; 3. Those who have undergone surgery within 4 weeks before the test or plan to perform surgery during the test; 4. Those who have participated in clinical trials of any drugs or medical devices within one month before the trial; 5. Those who have used external dermatologic drugs for the skin on the ventral side of the forearm within 1 month before the test; 6. Those who have used (vasoconstrictor or vasodilator) or drugs regulating blood flow within 1 month before the test (such as nitroglycerin, antihypertensive drugs, antihistamines, non steroidal anti-inflammatory drugs, aspirin, and over-the-counter cough/cold drugs containing antihistamines and/or phenylpropanolamine or phentolamine); 7. Those who have received inactivated vaccine inoculation within one month before screening, who have received live/attenuated vaccine inoculation within three months before screening, or who plan to receive inactivated/live/attenuated vaccine inoculation during the test period: 8. People with dermatitis or other skin diseases in the past; 9. The skin chroma of both arms is obviously different; 10. The skin is too dry and peeling; 11. People with skin scratch; 12. Those with strong hair on the ventral side of forearm; 13. Pregnant or lactating women, and subjects who cannot use one or more non drug contraceptives during the trial; 14. Those who have special requirements for diet and cannot follow the unified diet; 15. Drinking too much tea, coffee and/or caffeinated drinks (more than 5 cups, 1 cup=250 mL) every day; 16. Smokers or those who smoke more than 5 cigarettes a day 3 months before the test or cannot stop using any tobacco products during the test; 17. Alcoholics or those who regularly drank alcohol within 6 months before the test, that is, those who drank more than 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine) or could not stop using any alcoholic products during the test; 18. Those who use drugs poorly or have used soft drugs (such as marijuana) 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test: 19. Those with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or abnormal physical examination, electrocardiogram and laboratory examination have clinical significance (subject to the judgment of the clinical research doctor); 20. Subjects may not be able to complete the study due to other reasons or the investigators think they should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lab Value; plasma concentration ; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Qi Pei
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed