Facial sensitive skin
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be able to read documents and voluntarily sign informed consent form. 2. Age 18~60 years old (inclusive), either gender. 3. Patient meets ?the primary criteria? and ?at least one secondary criterion? defined in the China Clinical Guidelines for Sensitive Skin (2024 Edition) . The primary criteria? is that skin is prone to symptoms such as burning sensation, paroxysmal erythema and/or stingling, pruritus and tightness, with or without persistent erythema. Secondary conditions: SS-14 (the Sensitive Scale-14) score >18 points; lactic acid stinging test score >=3; capsaicin test >=3 points; facial dermatoses such as rosacea, seborrheic dermatitis, steroid-induced dermatitis, contact dermatitis, atopic dermatitis and lupus erythematosus tumidus are accompanied by symptoms of sensitive skin.
Exclusion criteria
Exclusion criteria: 1. Muscular or nervous system diseases diagnosed clearly in the past, such as facial muscular atrophy, facial paralysis, etc.. 2. Patients who have undergone facial sensitive skin treatment including but not limited to phototherapy, cold compress and factor introduction within 4 weeks prior to enrollment?, or skin cosmetic technique (PRP), intense pulsed light and exosomes ?within 3 months prior to enrollment?. 3. Those who have taken hormone drugs or other drugs that may interfere with the evaluation of curative effect within 3 months before screening. 4. Pregnant or lactating women, or male/female subjects planning pregnancy? (self or partner) ?within 6 months?. 5. Subjects with conditions significantly affecting efficacy evaluation? (e.g., conspicuous scars, hypertrichosis). 6. Suffering from systemic diseases, being on medication, or have been diagnosed with tumors. 7. Have dysfunction or failure of important organs. 8. Patients with a history of severe mental illness. 9. Patients with poor treatment compliance. 10. Have coagulation dysfunction or abnormal hematopoietic system. 11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, and HBV-DNA in peripheral blood is higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis test antibody positive. 12. Patients deemed by the investigator to be ineligible for participation in this clinical study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of skin physiological indexes;Investigator subjective evaluation;Safety evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject satisfaction; | — |
Countries
China
Contacts
Shenzhen Qianhai Shekou Free Trade Zone Hospital