None listed
Conditions
Interventions
Medical Device : The difference between the test equipment and the control equipment is the difference in the pulse duration of the laser irradiation, the test equipment can oscillate in picoseconds,
Sponsors
WONTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults younger than 19 and younger than 74 2. Those who have three or more photoreactive lentigo larger than 3 mm in diameter on the left and right sides of the face, respectively 3. Persons who agreed to take a picture facial 4. Persons who agree to and are willing to prohibit the use of topical / systemic steroids (Corticosteroids) or retinoids and topical / systemic skin whitening agents during the course of the trial 5. Persons who agree to use the same skin care products in facial area during the clinical trial period and who are willing to comply with them 6. I agree to use SPF 50 or more sunscreen every day on facial skin, avoiding excessive sunlight during the clinical trial period, and willingness to adhere to it 7. Persons who agree not to undergo other aesthetic procedures, surgery or scarring operations on the face during the clinical trial period 8. A woman who has been confirmed as negative in the pregnancy test and has agreed to be contraceptive during the trial period 9. Those who voluntarily agree to participate in the clinical trial and are willing to comply with the clinical trial protocol
Exclusion criteria
Exclusion criteria: 1. A person with a history of paralysis due to light 2. Those with facial infection, dermatitis, or rash 3. Keloid scarring, hypertrophic scarring, Abnormal wound healing history. 4. People with vitiligo, eczema, psoriasis 5. A person with a history of connective tissue such as systemic lupus erythematosus (Lupus) or scleroderma (Scleroderma) 6. Persons with a history of diseases that are stimulated by heat, such as herpes simplex and herpes zoster 7. Those who have been receiving radiotherapy or have a history of chemotherapy 8. A person with a malignant tumor in the face 9. People with a history of allergic reactions to local anesthetics 10. Persons who have used bleaching agents (Hydroquinone, Tranexamic acid, etc.), Isotretinoid (or Retinoid), light-sensitive drugs and steroids within the last 6 months 11. Those who have received facial cosmetic treatments such as laser, phototherapy, and surgery within the last 6 months or who have received filler treatment with collagen, hyaluronic acid filler or other materials 12. Those with heart disease, such as currently unregulated diabetes or resistant hypertension 13. Those who are currently taking anticoagulants or have anticoagulation 14. Those who have immunocompromised history or are taking immunosuppressive drugs 15. A person whose face is excessively tanned 16. Pregnant or lactating 17. If you have participated in other medical device or drug clinical trials within the last 90 days or are planning to participate in other clinical trials during this trial period 18. Any other person who, at the discretion of the examiner, judges of doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation of treatment(Pain, local and whole body check with Numberic Rating Scale);First effective evaluation of treatment(lightness index evaluation with spectrophotometer) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effective evaluation of treatment(count of lentigo, improvement factor of operator, satisfaction of subject) | — |
Countries
Korea, Republic of
Contacts
Public ContactSu Yoon
Kangbuk Samsung Medical Center
Outcome results
None listed