Warts are a relatively common skin infectious disease caused by the human papilloma virus, and are common among children of various age groups. Until now, treatment has been attempted in various ways such as cryotherapy, electrocautery, immunotherapy, injection or topical application of proliferation inhibitors such as anticancer drugs. However, there are cases where it does not respond well to such treatments and persists as a refractory lesion due to the site or duration of its occurrence, or the patient's systemic immune status. 
When warts occur on the palmar or plantar area, they may interfere with daily activities such as exercise and work, so treatment is absolutely necessary. However, conventional treatment methods such as cryotherapy involve pain and side effects such as blisters, infections, or nerve damage. Based on the fact that blood vessels are formed in proliferative wart lesions, the effectiveness and safety of wart treatment using a pulsed dye laser has been reported through several domestic and international clinical studies. In vascular laser, light energy is selectively absorbed by hemoglobin in the enlarged blood vessels and is converted into thermal energy, thus physical removal of the infected tissue can be expected through photodynamic physical damage. Vascular lasers with 585 and 595 nm wavelength ranges have been suggested as effective treatments for warts as results showed cure rate equal to or superior to conventional treatments such as cryotherapy.
Laser treatment is becoming a major treatment method for wart treatment as long-pulsed neodymium-yttrium aluminiun garnet (Nd:YAG) laser has been reported to be equally effective as a pulse dye laser. However due to its long-wavelength, 1,064 nm Nd:YAG penetrates to deep dermal layer, and accompanies severe pain which is the biggest limitation of the treatment.
Recently, a case report showed that intractable palmar warts were cured using a 755nm long pulse Alexandrite laser, which has a deeper penetrance than the pulse dye laser and has a higher absorption of hemoglobin. In addition, it was further reported that Alexandrite laser is equally effective on the treatment of vascular lesions compared to Long-pulse Nd:YAG, while reducing pain. 755nm Alexandrite laser and 1064nm Nd:YAG laser combined treatment are used in facial vascular lesions, it could be applied to treatment of cutaneous warts. We would like to apply the conventional method of single 1064nm versus dual 1064nm combined with 755nm wavelength to the treatment of cutaneous warts.
In this study, patients who visit hospital with two or more wart lesions on the palm or sole are divided into two groups. Test Group 1: Long-pulsed 755nm Alexandrite and 1,064nm Nd:YAG combined treatment and Test Group 2: long-pulsed 1,064 alone. The purpose of this study is to evaluate efficacy and safety by comparing both groups with previously reported studies.

Treatment

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 for 6 months. The subjects are divided into 2 groups, randomly assigned to test group 1 (Dual wavelength long-pulsed 755nm Alexandrite + 1,064nm Nd:YAG combination treatment) or test group 2 (long-pulsed 1,064nm Nd:YAG treatment alone), and maintai the assigned group until the end of the study. The subjects receive a total of 4 laser treatments at 3-4 week intervals, take clinical pictures of the wart lesions on the treatment site before the procedure and at all visits, and record the number of lesions.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Test group 1 Combined wavelength 
- Dual Wavelength Long-pulsed 755nm Alexandrite/1,064nm Nd:YAG 
  : Alexandrite – Fluence (20 J/cm2), spot size (5 mm), pulse width (1.5 ms), 1 pass 
  : Nd:YAG – Fluence (200 J/cm2), spot size (5 mm), pulse width (30 ms), 1 pass 
* In the case of combined treatment group, first proceed with Alexandrite laser 1pass and then Nd:YAG laser.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Test group 2 Single wavelength
- Long-pulsed 1,064nm Nd:YAG 
: Nd:YAG – Fluence (200 J/cm2), spot size (5 mm), pulse width (30 ms), 2 passes

Gender

Age

Description

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.

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).

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.

At the 5th visit at week 16, one month after 4 laser treatments

The proportion of lesions with complete clearance, partial clearance, and treatment failure after 4 laser treatments compared to baseline, evaluated through dermoscope photographs.

At the 5th visit at week 16, one month after 4 laser treatments

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.

4 weeks after the first laser treatment (visit 2), 8 weeks after (visit 3), 12 weeks after (visit 4), 4 weeks after the last treatment (visit 5)

Subjective satisfaction evaluation of the subject

At the 5th visit at week 16, one month after 4 laser treatments

10-point Visual Analog Scale (VAS) of pain due to the procedure evaluated by the subject

At the 5th visit at week 16, one month after 4 laser treatments