None listed
Conditions
Interventions
Medical Device : This is a study to evaluate the stability and effectiveness of Dual Wavelength Long-pulsed 755nm Alexandrite/1,064nm Nd:YAG for cutaneous wart treatment through follow-up observation
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must satisfy all of the following criteria to participate in this clinical trial. (1) Adults aged 19 to 65 years old. (2) Patients with two or more cutaneous wart lesions on the palms or soles. (3) A person who has voluntarily signed a written consent after sufficiently explained the purpose and contents of the test prior to the clinical trial (4) Those who can follow-up during the clinical trial period. (5) A person who has agreed to discontinue other dermatological treatments or treatments within the scope permitted by the research team at the treatment site and adjacent areas during the clinical trial period.
Exclusion criteria
Exclusion criteria: Anyone who meets any of the following items cannot participate in this clinical trial. (1) If you do not agree with or have not filled out the consent form. (2) If you are allergic to a local anesthetic (lidocaine). (3) Pregnant or lactating women. (4) Patients judged to be unsuitable by the person in charge of the clinical trial for the following conditions 1) If there is an infectious or inflammatory skin disease at the treatment site 2) In case of keloid or disease with collagen or elastic fiber. 3) If you have a chronic wasting disease (asthma, diabetes, etc.) 4) When there is a risk of bleeding by taking anticoagulants 5) If you have an autoimmune disease 6) Those with psychiatric problems 7) People with acute illness (5) Other than the above, if it is judged by the person in charge of the clinical trial that there is difficulty conducting the clinical trial (including illiteracy and other foreigners excluded).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of complete clearance, partial clearance, and treatment-failed lesions in each test group evaluated through photographs by independent evaluators after the final application of the clinical trial medical device compared to the baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of lesions with complete clearance, partial clearance, and treatment failure after 4 laser treatments compared to baseline, evaluated through dermoscope photographs.;5-point scale Global Aesthetic Improvement Scale (GAIS) evaluated through clinical picture comparison by two independent dermatologists who remain blinded at visit 2, 3, 4, and 5.;Subjective satisfaction evaluation of the subject;10-point Visual Analog Scale (VAS) of pain due to the procedure evaluated by the subject | — |
Countries
Korea, Republic of
Contacts
Public ContactSujin Park
Yonsei University Health System, Severance Hospital
Outcome results
None listed