upper lip scars
Conditions
Interventions
Microplasma radiofrequency treatment group:Microplasma radiofrequency will be used to treat upper lip scars
CO2 laser treatment group:CO2 laser will be used to treat upper lip scars
Sponsors
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
5 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Patients who diagnosed with unilateral cleft lip 2. Must understand and voluntarily sign an informed consent form 3. Must be able to adhere to the study visit schedule and other protocol requirements 4. Patients who undergoing post-surgical secondary repair of cleft lip scar 5. The patient or the patient's guardian agrees to participate in the study and signs the informed consent 6. Not participating in other clinical trials
Exclusion criteria
Exclusion criteria: 1. Inability to provide voluntary informed consent 2. Participation in a clinical trial of another drug, or device administered to the treatment area, within 6 months prior to enrollment or during the study 3. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser procedures, radiofrequency therapies 4. History of hypertrophic scars or keloids 5. Acute inflammation or infection near the treatment site. 6. Hypersensitivity to light exposure 7. Any use of medication that is known to increase sensitivity to light according to the Investigator’s discretion 8. Pregnancy or breastfeeding 9. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication 10. History of squamous cell carcinoma or melanoma in the treatment area 11. History of epidermal or dermal disorders 12. History of connective tissue disease, such as systemic lupus erythematosus or Scleroderma 13.History of disease stimulated by heat 14.History of pigmentary disorder 15. History of oral isotretinoin within 6 months 16.Excessively tanned or active sun tan in the area to be treated 17.As per the Investigator’s discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VSS ; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS;Patient satisfaction at final follow-up(5-point Likert scale);Changes in the length of the cleft-side of upper lip skin immediately after surgery and at the final follow-up;changes in scar size before and after two different treatments separately; | — |
Countries
China
Contacts
Public ContactYongqian Wang
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed