A single-blinded, split-face study for comparative evaluation on the efficacy and stability of the treatment of solar lentigo by picosecond Nd:YAG laser(Picocare 450)
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0002524
- Lead Sponsor
- WONTECH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 49
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary effective evaluation of treatment(count of lentigo, improvement factor of operator, satisfaction of subject)