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

NCT05768893 | Completed DMC FDA Device

• 1 other identifier: 0141-21-RMB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Viral Wart

Keywords

viral warts; recalcitrant; treatment; Er:YAG laser; long-pulsed Nd:YAG laser

Outcome Measures

Primary Outcomes (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.

  5 weeks following the treatment.

Secondary Outcomes (4)

• Side effects

  5 weeks following the treatment.

• Age of the patient.

  5 weeks following the treatment.

• Gender of the patient.

  5 weeks following the treatment.

• Location of the warts.

  5 weeks following the treatment.

Study Arms (2)

Group 1: Combined Er:YAG laser and long-pulsed Nd:YAG laser group

EXPERIMENTAL

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

Group 2: Er:YAG laser group.

ACTIVE COMPARATOR

This group included 120 wart lesions, treated with Er:YAG laser only.

Device: Er:YAG Laser 2940nm

Interventions

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

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

Group 1: Combined Er:YAG laser and long-pulsed Nd:YAG laser group

Er:YAG Laser 2940nm DEVICE

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

Group 2: Er:YAG laser group.

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Related Publications (10)

• 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.

  PMID: 33314577 BACKGROUND

• 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.

  PMID: 32640061 BACKGROUND

• 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.

  PMID: 23205250 BACKGROUND

• 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.

  PMID: 24218179 BACKGROUND

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

  PMID: 2156916 BACKGROUND

• 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.

  PMID: 28466193 BACKGROUND

• 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.

  PMID: 10369554 BACKGROUND

• 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.

  PMID: 21774662 BACKGROUND

• 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.

  PMID: 7712088 BACKGROUND

• 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.

  PMID: 8647965 BACKGROUND

MeSH Terms

Conditions

Warts

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Ziad Khamaisi, MD

  Rambam Health Care Campus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary assessor was given two photographs of each lesion, the first is the unmarked photograph copy (doesn't indicate to what group each lesion belongs) that was taken prior to the procedure, the second is the photograph that was taken in the follow up 5 weeks later. Assessments based on the two photographs were conducted by the primary assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 15, 2023
• Study Start: May 1, 2022
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)