Evaluation of Combined Treatment With Er:YAG & Nd:YAG Lasers for the Treatment of Recalcitrant Warts

March 14, 2023 updated by: Rambam Health Care Campus

Evaluation of Combined Treatment With Er:YAG Laser and Long-pulsed Nd:YAG Laser for the Treatment of Recalcitrant Warts: a Prospective Randomized Controlled Trial

Background: Viral warts are common infectious skin disease induced by human papillomavirus (HPV). Lasers have been used for warts treatment in recent years with variable success rates.

Objective: The goal of this clinical trial is to prospectively evaluate combined treatment with Er:YAG laser and long-pulsed Nd:YAG laser compared to Er:YAG laser for the treatment of recalcitrant warts after one session. The main question it aims to answer is:

Does adding a treatment of long-pulsed Nd:YAG laser to Er:YAG laser in the same treatment session to the same wart have more curing effect than using the Er:YAG laser alone? This study included 240 lesions from 24 patients. All the lesions were diagnosed clinically as recalcitrant warts after failure of topical treatment and Cryotherapy. 120 lesions underwent a combined therapy of Er:YAG and long-pulsed (LP) Nd:YAG lasers, and the remaining 120 lesions underwent Er:YAG laser therapy only. The clearance rate was evaluated 5 weeks after and classified by three-graded evaluation: complete response, partial response, and poor response.

Researchers will compare the 120 treated warts with the combined lasers therapy to the 120 treated warts treated with Er:YAG laser alone to see if adding the Nd:YAG laser therapy has an additional curing value.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Viral warts are benign epithelial proliferations, characteristically 1-20 mm in diameter, that develop secondary to infection of keratinocytes by human papilloma virus (HPV). HPV comprises a large group of approximately 120 genotypes that infect the epithelia of the skin or mucosa. Warts are a common dermatological complaint, with an estimated incidence of 5%-20% in children and adults, with peak incidence reported during teenage years. Patients often express a significant reduction in quality of life due to this cosmetic nuisance, as well as functional problems and physical discomfort when they occur on the palms of the hands and soles of the feet. Therefore, cutaneous warts are one of the most common pathologies treated by the clinical dermatologist.

Although warts may eventually spontaneously disappear once the immune system finds a way to eradicate the virus, the time taken for this to occur varies and can range from months to years. Managing recalcitrant warts may require more than one treating session. Chemical destruction can be induced with salicylic acid, cantharidin, formaldehyde, or glutaraldehyde, among other agents. Chemotherapeutic agents include podophyllin, podophyllotoxin, 5-fluorouracil, and bleomycin. Allergic contact agents used against recalcitrant warts include dinitrochlorobenzene and squaric acid dibutyl ester. More recently, immunomodulators such as interferon, systemic retinoids, cimetidine, and topical imiquimod have been used. The used methods of physical destruction include surgical excision, electrodesiccation, cryosurgery, and pulsed dye or carbon dioxide laser therapy.

Most of the methods mentioned above have their drawbacks and side effects. Surgical methods have proven somewhat effective but have their disadvantages of pain and long recovery periods and may offer incomplete and superficial results leading to high recurrence rates. Topical management requires the application of drugs for long durations and treatment success is, therefore, highly dependent on patient compliance.

Lasers are new methods of energy-based devices for treating warts. Er:YAG laser (like CO2 laser) is an ablative laser emitting at a wavelength of 2940 nm and highly absorbed by water. It is considered a safe treatment for viral warts, However, in many patients, mainly those with plantar warts, a significant rate of relapse may occur, requiring additional therapy. Recently, the long-pulsed (LP) 1064 nm Nd:YAG laser has attracted attention in the treatment of palmoplantar warts. The mechanism of the LP Nd:YAG laser is different from the Er:YAG laser. It targets the dermal blood vessels that supply infected cells and destroy them via photothermolysis mechanism. However, the limitations of this method are that the treatment usually requires several sessions, and the clearance rate after one session ranges between 14-22%.

This prospective study evaluates the treatment efficacy of an Er:YAG laser alone compared to a combination of Er:YAG followed by LP Nd:YAG after one session of recalcitrant warts. The investigators hypothesize that combining the two mechanisms of ablating the wart and coagulating the blood supply may lead to a higher wart clearance rate after a sole treatment session.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who were clinically diagnosed with recalcitrant warts after two or more failed treatment lines with Cryotherapy and topical treatments.
  2. Patients above the age of 8 and under the age of 80.

Exclusion Criteria:

  1. The use of topical treatment for wart lesions in the past month.
  2. Methods of physical destruction of the lesions in the past month such as surgical excision, electrodesiccation, cryosurgery or laser were excluded.
  3. Patients with single wart lesion were excluded.
  4. Pregnant and breast- feeding patients.
  5. Patients on anticoagulant drugs.
  6. Children below the age of 8.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Combined Er:YAG laser and long-pulsed Nd:YAG laser group
This group included 120 wart lesions, treated with Er:YAG laser followed by LP Nd:YAG laser after 1-2 minutes. Cryo 6 (Zimmer Medizin Systems) was used to cool the lesions before, during and after applying the Nd:YAG laser.
Device: Long-Pulsed Nd:YAG Laser 1064nm & Er:YAG Laser 2940nm
Warts with this intervention treated firstly with the Er:YAG laser, followed by the Nd:YAG laser in the same session.
Active Comparator: Group 2: Er:YAG laser group.
This group included 120 wart lesions, treated with Er:YAG laser only.
Device: Er:YAG Laser 2940nm
Warts with this intervention treated only with the Er:YAG laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the curing rate of the treatment between the two groups.
Time Frame: 5 weeks following the treatment.

The cure rate of the treatment was classified by a three-grade evaluation according to the clearance at the end of therapy:

  • Complete response was considered when 100% of the wart disappeared.
  • Partial response was considered when 50-99% of the wart was disappeared.
  • Poor response was considered when less than 50% of the wart was disappeared.

The disappeared portion of the wart was estimated visually based on two photographs, the first taken minutes before the treatment, and second taken 5 weeks after the treatment.
5 weeks following the treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 5 weeks following the treatment.
Including Blisters, Crusts, Escars, Hypopigmentation, Hyperpigmentation, Hypertrophic scars.
5 weeks following the treatment.
Age of the patient.
Time Frame: 5 weeks following the treatment.
Assess any correlations between the curing rate and age of the patient. This will be tested with a generalized linear model, namely a random intercept logistic regression that accounts for patient differences.
5 weeks following the treatment.
Gender of the patient.
Time Frame: 5 weeks following the treatment.
Assess any correlations between the curing rate and gender of the patient. This will be tested with a generalized linear model, namely a random intercept logistic regression that accounts for patient differences.
5 weeks following the treatment.
Location of the warts.
Time Frame: 5 weeks following the treatment.

Assess if there is any correlations between the curing rate location of the wart. the warts locations that were tested: Palmar, Plantar, Periungual.

This will be tested with a generalized linear model, namely a random intercept logistic regression that accounts for patient differences.
5 weeks following the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Study Director: Ziad Khamaisi, MD, Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

September 28, 2022

Study Completion (Actual)

September 28, 2022

Study Registration Dates

First Submitted

February 26, 2023

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0141-21-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Risk of re-identification of participant data, reuse of data for purposes that had not been approved by patients, or for unfair commercial purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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