Rosacea
Conditions
Interventions
Test group :Test side receives Triple Lipid Restore 2:4:2 for skin repair
Control group:Control side applied base moisturizing cream
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged 18-50 years; 2. Subjects with Fitzpatrick skin type II-IV; 3. Subjects with mild to moderate erythema (i.e., CEA score 2-3) as the main manifestation of erythematous vasodilated rose acne, and the severity of bilateral erythema on the face was consistent; 4. There is no urgent drug, physical and laser treatment need or do not want to accept the above rosacea treatment program; 5. Subjects who first use Triple Lipid Restore 2:4:2; 6. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures; 7. Subjects understand the nature of the study and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Receiving oral retinoic acid, laser therapy, collagen or botulinum toxin injection or chemical peeling and other medical beauty items/surgery for the treatment of rosacea within 3 months before enrollment; 2. Oral antibiotics (such as doxycycline) within 1 month before enrollment; 3. Use of external application of drugs and skin care products for the treatment of rose acne within 2 weeks before enrollment; 4. Presence of active acne or papulopustular rosacea; 5. Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives); 6. Presence of autoimmune diseases (such as lupus erythematosus, dermatomyositis, etc.) that may affect the treatment of rose acne; 7. Presence of severe systemic diseases (such as sepsis, bacteremia, toxemia, etc.); 8. Subjects with known hypersensitivity to skin care ingredients; 9. Female subjects who are pregnant, lactating or plan to become pregnant; 10. Subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy, sunbathing, botulinum toxin injection during the treatment; 11. Subjects who are participating in other drug or medical device clinical trials; 12. Other subjects who are not suitable for this study as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Clinician Erythema Assessment (CEA) score on face at 28 days after enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| CEA score improvement (7, 14 days after enrollment);Rate of successful improvement in CEA score (7, 14, 28 days after enrollment);CEA score significant improvement rate (7, 14, 28 days after enrollment);Improvement in erythema checklist score (7, 14, 28 days after enrollment);Change in Erythema Index (EI) (7, 14, 28 days after enrollment);Change in melanin index (MI) (7, 14, 28 days after enrollment);Change in stratum corneum water content (7, 14, 28 days after enrollment);Change in transepidermal water loss (7, 14, 28 days after enrollment);Change in sebum rate (7, 14, 28 days after enrollment);Rosacea quality of life index (7, 14, 28 days after enrollment);Subject 's overall satisfaction score (7, 14, 28 days after enrollment); | — |
Countries
China
Contacts
Public ContactBo YU
Peking University Shenzhen Hospital
Outcome results
None listed