None listed
Conditions
Interventions
Hydrogel Microneedle Extraction Test Group:Following the administration of the drug according to the protocol, skin interstitial fluid was extracted using a microneedle patch.
Skin Lightening Test Group:Following the administration of the drug according to the protocol, skin color was measured using a spectrophotometer.
Sponsors
Huzhou Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 60 (inclusive) on the day of signing the informed consent form, both males and females; male body weight >= 50 kg, female body weight >=45 kg; body mass index (BMI) within the range of 19.0–30.0 kg/m² (including critical values); 2.Commitment to refrain from using creams, moisturizers, or similar products on the forearm skin from 24 hours before drug administration until the end of the trial (except for the screening of "responders"); 3.Commitment to avoid bathing without authorization during the trial, refraining from exercising with the arms, and avoiding any strenuous or fatigue-inducing activities; 4.Individuals who demonstrate a sufficient vasoconstrictive response to fluticasone propionate cream, i.e., "responders"; 5.All subjects with reproductive capacity (including their partners) must have no plans for conception from the time of signing the informed consent until three months after the trial and voluntarily adopt appropriate and effective non-pharmacological contraceptive measures, with no plans for sperm or egg donation; 6.Voluntary participation in this clinical trial, ability to communicate effectively with the investigator, compliance with all study requirements, and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Individuals with a history or current diagnosis of major diseases in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, or metabolic systems, or any other condition that, in the investigator's opinion, may interfere with the study results or pose potential risks to the subject's participation; 2.Individuals with a history of allergies (defined as hypersensitivity to two or more medications, foods, or pollen), or those with a history of drug/food allergies, skin conditions (such as rash, eczema, pruritus, etc.), or severe skin diseases, who are deemed unsuitable for participation by the investigator; 3.Use of topical medications on the volar forearm within 1 month prior to screening; 4.Any clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests (including hematology, blood biochemistry, urinalysis, coagulation function, infectious disease screening), pregnancy test (for females only), or 12-lead electrocardiogram at the time of screening, as determined by the investigator; 5.Participation in clinical trials of other topical dermatological drugs within 1 month prior to screening; 6.Use of any prescription drugs, over-the-counter medications, Chinese patent medicines, herbal products, or health supplements within 2 weeks prior to screening; 7.Pregnant or lactating women; female subjects who are planning pregnancy from 14 days prior to screening until 3 months after the last dose, or male subjects (or their partners) planning pregnancy during the study period or within 3 months after study completion, and those unwilling to adopt one or more non-pharmacological contraceptive measures (such as complete abstinence, condoms, etc.) during the study period; 8.Any other circumstances deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration-time curve area from 0 to infinity;The area under the drug concentration-time curve from time 0 to the last sample collection time t at which the concentration can be accurately measured;Cmax;Measured Result - Area Under the Time Curve; | — |
Countries
China
Contacts
Public ContactChen Yingrong
Huzhou Center Hospital
Outcome results
None listed