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Viral WartNCT05768893

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

A study testing Long-Pulsed Nd:YAG Laser 1064nm & Er:YAG Laser 2940nm and Er:YAG Laser 2940nm in people with Viral Wart, run by Rambam Health Care Campus at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 to 80 years
Conditions the study is for
Viral Wart
What is being tested?
Long-Pulsed Nd:YAG Laser 1064nm & Er:YAG Laser 2940nm and Er:YAG Laser 2940nm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteIsrael
Study dates
1 May 2022to 28 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Rambam Health Care Campus

    Haifa, 3109601

Other trials in Israel

About this study

Official title: 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:

Read more

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.

Read the 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.

Conditions
Viral Wart
Being tested
Long-Pulsed Nd:YAG Laser 1064nm & Er:YAG Laser 2940nm, Er:YAG Laser 2940nm
Keywords
viral warts, recalcitrant, treatment, Er:YAG laser, long-pulsed Nd:YAG laser
Medical subject headings
Warts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Long-Pulsed Nd:YAG Laser 1064nm & Er:YAG Laser 2940nmDevice

    Warts with this intervention treated firstly with the Er:YAG laser, followed by the Nd:YAG laser in the same session.

  • Er:YAG Laser 2940nmDevice

    Warts with this intervention treated only with the Er:YAG laser.

Study groups in NCT05768893
Study groupRoleWhat they receive
Group 1: Combined Er:YAG laser and long-pulsed Nd:YAG laser groupExperimentalThis 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.
Receives: Device: Long-Pulsed Nd:YAG Laser 1064nm & Er:YAG Laser 2940nm
Group 2: Er:YAG laser group.Active comparatorThis group included 120 wart lesions, treated with Er:YAG laser only.
Receives: Device: Er:YAG Laser 2940nm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the curing rate of the treatment between the two groups.

    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.

    Measured: 5 weeks following the treatment.

Secondary outcomes (4)
  1. Side effects

    Including Blisters, Crusts, Escars, Hypopigmentation, Hyperpigmentation, Hypertrophic scars.

    Measured: 5 weeks following the treatment.

  2. Age of the patient.

    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.

    Measured: 5 weeks following the treatment.

  3. Gender of the patient.

    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.

    Measured: 5 weeks following the treatment.

  4. Location of the warts.

    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.

    Measured: 5 weeks following the treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start1 May 2022
  3. Primary completion28 Sep 2022
  4. Study completion28 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This randomized controlled trial included 240 lesions from 24 patients diagnosed with recalcitrant warts. Each wart of the 240 was given a number and photographed. In cases when the patient had an uneven number of warts, one wart was excluded randomly. Then, the warts of each patient were randomly divided into two groups using computerized randomization and assigned to group 1 or group 2. Each group consisted of 120 warts. Group 1: Combined Er:YAG laser and long-pulsed Nd:YAG laser group. Group 2: Er:YAG laser group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05768893
Sponsor's protocol ID
0141-21-RMB
Status last verified
Mar 2023
First submitted
26 Feb 2023
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Risk of re-identification of participant data, reuse of data for purposes that had not been approved by patients, or for unfair commercial purposes.

Publications

  • Iranmanesh B, Khalili M, Zartab H, Amiri R, Aflatoonian M. Laser therapy in cutaneous and genital warts: A review article. Dermatol Ther. 2021 Jan;34(1):e14671. doi: 10.1111/dth.14671. Epub 2020 Dec 29.

    PubMed 33314577
  • Zorman A, Koron N. Wart removal without anesthesia using long-pulse 1064-nm Nd:YAG laser. J Cosmet Dermatol. 2021 Feb;20(2):506-512. doi: 10.1111/jocd.13593. Epub 2020 Jul 16.

    PubMed 32640061
  • Azizjalali M, Ghaffarpour G, Mousavifard B. CO(2) Laser therapy versus cryotherapy in treatment of genital warts; a Randomized Controlled Trial (RCT). Iran J Microbiol. 2012 Dec;4(4):187-90.

    PubMed 23205250
  • El-Mohamady Ael-S, Mearag I, El-Khalawany M, Elshahed A, Shokeir H, Mahmoud A. Pulsed dye laser versus Nd:YAG laser in the treatment of plantar warts: a comparative study. Lasers Med Sci. 2014 May;29(3):1111-6. doi: 10.1007/s10103-013-1479-y. Epub 2013 Nov 12.

    PubMed 24218179
  • Cobb MW. Human papillomavirus infection. J Am Acad Dermatol. 1990 Apr;22(4):547-66. doi: 10.1016/0190-9622(90)70073-q.

    PubMed 2156916
  • Hsu VM, Aldahan AS, Tsatalis JP, Perper M, Nouri K. Efficacy of Nd:YAG laser therapy for the treatment of verrucae: a literature review. Lasers Med Sci. 2017 Jul;32(5):1207-1211. doi: 10.1007/s10103-017-2219-5. Epub 2017 May 2.

    PubMed 28466193
  • El-Tonsy MH, Anbar TE, El-Domyati M, Barakat M. Density of viral particles in pre and post Nd: YAG laser hyperthermia therapy and cryotherapy in plantar warts. Int J Dermatol. 1999 May;38(5):393-8. doi: 10.1046/j.1365-4362.1999.00719.x.

    PubMed 10369554
  • Oni G, Mahaffey PJ. Treatment of recalcitrant warts with the carbon dioxide laser using an excision technique. J Cosmet Laser Ther. 2011 Oct;13(5):231-6. doi: 10.3109/14764172.2011.606465.

    PubMed 21774662
  • Brodell RT, Bredle DL. The treatment of palmar and plantar warts using natural alpha interferon and a needleless injector. Dermatol Surg. 1995 Mar;21(3):213-8. doi: 10.1111/j.1524-4725.1995.tb00155.x.

    PubMed 7712088
  • Yilmaz E, Alpsoy E, Basaran E. Cimetidine therapy for warts: a placebo-controlled, double-blind study. J Am Acad Dermatol. 1996 Jun;34(6):1005-7. doi: 10.1016/s0190-9622(96)90279-0.

    PubMed 8647965

Questions about this trial

What is this clinical trial studying?

A study testing Long-Pulsed Nd:YAG Laser 1064nm & Er:YAG Laser 2940nm and Er:YAG Laser 2940nm in people with Viral Wart, run by Rambam Health Care Campus at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the curing rate of the treatment between the two groups. (time frame: 5 weeks following the treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05768893, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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