Photo-aging
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in the study: 1) Chinese subjects aged 18-65 years (inclusive); 2) Subjects with Fitzpatrick skin type II-IV; 3) Subjects who have consistent facial skin status on both sides and plan to receive fractional CO2 laser treatment. 4) Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures. 5) Subjects understand the nature of the study and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Subjects were not included in the study if they met any of the following exclusion criteria: 1) Subjects with photosensitive skin or photosensitization-related diseases; 2) Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives); 3) Subjects with hypertrophic scars or scar constitution; 4) Subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead to skin color changes; 5) Subjects who have received steroid/phototoxic drugs or laser treatment on the face within 3 months before enrollment; 6) Subjects with a history of sun exposure within 2 weeks prior to enrollment; 7) Subjects who are known to have contraindications to CO2 fractional laser therapy or CE and RBE use (such as hypersensitivity to skin care components); 8) Subjects who are known to have the intended treatment site at the onset of acne and have infection and inflammation; 9) Female subjects who are pregnant, lactating or planning to become pregnant; 10) Subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy and sunbathing during the treatment; 11) Subjects who are participating in other drug or medical device clinical trials; 12) Other subjects who are not suitable for participating in this study as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema index at day 14 post-procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythema index change from baseline (1, 3, 7, 14 days post-procedure);Change from baseline in edema score (1, 3, 7, 14 days post-procedure);Change from baseline in melanin index (MI) (1, 3, 7, 14 days post-procedure);Change from baseline in stratum corneum water content (1, 3, 7, 14 days post-procedure);Change from baseline in transepidermal water loss (1, 3, 7, 14 days post-procedure);Change from baseline in sebum percentage (1, 3, 7, 14 days post-procedure);Decrustation (1, 3, 7, 14 days post-procedure);Subject 's overall satisfaction (1, 3, 7, 14 days post-procedure); | — |
Countries
China
Contacts
Shanghai Skin Disease Hospital