Repair of skin barrier function damage in patients with sensitive skin
Conditions
Interventions
Sponsors
Chinese People's Liberation Army Air Force Specialty Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~65 years old (including boundary value), gender is not limited; 2. According to the diagnostic criteria for sensitive skin in the Guidelines for Clinical Diagnosis and Treatment of Sensitive Skin in China (2024 Edition), the following conditions must be met at the same time: (1) the skin is prone to symptoms such as burning, paroxysmal redness and/or stinging, itching and tightness when the skin is slightly stimulated by the outside world, with or without persistent erythema; (2) Sensitivity scale assessment, SS-10 score > 13 points; (3) Lactate stinging test score>=3 points; 3. Agree to maintain existing skincare habits and not use other facial treatments and skincare products related to the study during the study period; 4. Those who have signed the informed consent form and are able to cooperate with the treatment and follow-up plan.
Exclusion criteria
Exclusion criteria: 1. Those who have used drugs for the treatment of facial skin diseases such as rosacea, seborrheic dermatitis, hormone-dependent dermatitis, contact dermatitis, atopic dermatitis and swollen lupus erythematosus within 4 weeks prior to screening, and those who are expected to require medical or non-drug treatment of the above facial skin diseases during the study period; 2. Presence of infection of facial skin, history of skin cancer or other tumors; 3. The subject's facial skin has obvious pigmentation, birthmarks, inflammation, pigmented nevi, hirsutism, etc., which are judged by the investigator to affect the efficacy evaluation; 4. The treatment area has received wrinkle and exfoliation treatments such as skin peeling and abrasion within six months, or other plastic and aesthetic treatments such as radiofrequency therapy, ultrasound, laser and injection treatment within three months; 5. Those who need to be exposed to the sun for a long time and work outdoors; 6. During the onset of the disease, systemic or topical use of immunosuppressants, antihistamines or glucocorticoids and other drugs that have therapeutic effects on sensitive skin; 7. Patients who plan to use any adjuvant therapy or concomitant therapy to treat sensitive skin during the study; 8. With abnormal liver and kidney function [ALT, AST> 3 times the upper limit of normal; Serum creatinine >1.5 times the upper limit of normal], severe cardiovascular and cerebrovascular diseases, which are assessed by the investigator to affect the efficacy and safety assessment; 9. Patients with immunocompromise, diabetes, chronic serious infection, and malignant tumors; 10. Epilepsy and severe mental illness, alcoholism/addiction, drug abuse and dependence; 11. During the study period, the education of patients with sensitive skin should not be strictly followed and the predisposing factors should be avoided; 12. Those who have a history of allergy to external collagen products and are allergic to the devices and their components used in this test; 13. Have a history of facial scarring or poor wound healing; 14. Patients who have participated in other clinical trials that may have a direct or indirect impact on this clinical trial in the past 3 months; 15. Pregnant or lactating women; 16. Other conditions that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in SS-10 after 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in SS-10 after 2 weeks of treatment;Positive lactic acid sting test at 2 and 4 weeks of treatment;Change from baseline in transepidermal water loss (TEWL) at 2 and 4 weeks of treatment;Change from baseline in stratum corneum hydration (SCH) at 2 and 4 weeks of treatment;Change from baseline in sebum content at 2 and 4 weeks of treatment;Skin surface pH at 2 and 4 weeks of treatment;Change from baseline in skin erythema index at 2 and 4 weeks of treatment;Patient comfort ratings; | — |
Countries
China
Contacts
Public ContactCai Hong
Chinese People's Liberation Army Air Force Specialty Medical Center
Outcome results
None listed