Efficacy and Safety of Topical Methotrexate Gel 1% Coupled With Microneedling in Treatment of Warts

March 18, 2022 updated by: Khulood Fadhl Ahmed Alhakami, Assiut University

Efficacy and Safety of Topical Methotrexate Gel 1% Coupled With Microneedling in Treatment of Warts : A Prospective Controlled Randomized Trial

To study the clinical efficacy of the topically applied MTX hydrogel preparation combined with microneedling to increase drug delivery and efficacy in comparison with cryotherapy in treatment of warts.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Warts are benign proliferation of skin and mucosa caused by the human papilloma virus (HPV). Currently, over 170 HPV types have been identified. Certain HPV types tend to infect skin at anatomical sites, for an example, palmoplantar warts are usually caused by Serotypes 1, 2, and 4; however, warts of any HPV type may occur at any site. Warts are transmitted by direct or indirect contact, and predisposing factors include disruption to the normal epithelial barrier.

There are several modalities for treatment of warts including cryotherapy, electrocoagulation, topical salicylic acid, topical 5-fluorouracil, and laser surgery. All these treatment options can be painful, time-consuming, and/or expensive, and none is considered the gold standard.

Treatments for warts have also included intralesional injections of tuberculin purified protein derivative (PPD), measles, mumps, and rubella vaccine (MMR), and Candida albicans antigen (candidin). This treatment approach is known as intralesional immunotherapy as it is thought that these modalities activate the immune system to recognize the virus, leading to wart clearance

. MTX as an antimetabolite and antifolate drug is a time-tested effective treatment extensively used orally or parenteral in various autoimmune disorders like psoriasis, psoriatic arthritis, alopecia areata, lupus erythematosus, and rheumatoid arthritis in low to moderate doses with good efficacy, safety, and tolerability on a long-term basis

MTX is appropriate for rapidly growing tumors since it inhibits DNA synthesis in actively dividing cells. MTX is a folic acid analog that binds to the dihydrofolate reductase, blocking the formation of tetrahydrofolate and preventing the synthesis of the purine nucleotide thymidine .

Antiviral effect of MTX was observed in the treatment of Zika virus infected cells explaining the antiviral effect of MTX through inhibition of dihydrofolate reductase ..

A literature review shows that intralesional MTX has been successfully used for several indications with no complications reported.

Unlike systemic MXT, topical preparations of the drug, that was adapted for the treatment of localized lesions, showed nonsignificant related hepatotoxic and hematologic adverse effects .

Previous studies used intralesional MTX injection in the treatment of viral warts with different concentrations and revealed that intralesional MTX was less effective in treating plantar warts .

Since MTX is used for various diseases via different routes of administration, the development of novel drug delivery systems to improve its pharmacokinetic properties and targetability is a necessary step for future investigations .

Controlling the burst release and the introduction of new routes of administration would be possible if the drug could be formulated using different delivery systems. Among various drug delivery systems proposed for MTX delivery, great attention has been directed to hydrogels due to their unique and attractive characteristics .

Microneedling is a fine needle that penetrates the skin to induce micro-injuries leading to production of collagen fibers and release of growth factors .

Microneedling has been used as an adjuvant therapy helping a drug delivery and also used in treatment of various dermatologic diseases .

In this study, the investigators chose the hydrogel formulation at a concentration of 1%w/v as a topical MTX form coupled with microneedling to increase the efficacy of methotrexate in treatment of warts. Hydrogel used will be optimized for biocompatibility, consistency and chemical compatibility with methotrexate.

Study Type

Interventional

Enrollment (Anticipated)

68

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 Contact

  • Name: Eman R Mohamed, Professor
  • Phone Number: +201005298992
  • Email: e_riad@yahoo.com

Study Contact Backup

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18 years up to 60 years old.
  • Patients with plantar or common warts.

Exclusion Criteria:

  • pregnancy and lactation
  • immunosuppression or being under any kind of treatment causing absolute or relative immunosuppression.
  • history of any bleeding, clotting disorder or using anticoagulants.
  • chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
  • concurrent use of systemic or topical treatments of warts .

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: topical methotrexate hydrogel 1% coupled with microneedling
patients who will receive topical methotrexate hydrogel 1% coupled with microneedling
Combination product: topical methotrexate hydrogel 1% coupled with microneedling.
Microneedling will be performed on each wart for a maximum 5 lesions per patient using dermapen (Ostar rechargeable dermapen, OB-DG 03N, Ostar Beauty Sci-Tech Co, Beijing, China) supplied with 12 needles arranged in rows. The penetration depth was adjusted at 2-mm, endpoint was pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the wart. Then topical methotrexate 1% gel will be applied on the lesions every session.
Active Comparator: cryotherapy
patients who will receive cryotherapy
Other: Liquid nitrogen

The wart is frozen for 10 to 30 seconds until a 1- to 2-mm ice ball halo surrounds the targeted area.

The sessions were performed every 2 week until complete clearance for a maximum of six sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete resolution of all treated wart(s).
Time Frame: 8 weeks

Proportion of participants with total remission of wart(s) at the end of the intervention in the two arms of the clinical trial assessed by the investigator and photographic evaluation .

Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings).
8 weeks
Partial resolution
Time Frame: 8 weeks

Number of subjects achieving partial resolution of treated wart(s) at the end of the intervention in the two arms of the clinical trial assessed by the investigator, photographic evaluation and The following grading system :

Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response.

Moderate response: partial responders show 25 to 75% improvement. No or minimal response: less than 25% decrease in size/numbers of all warts. the stud
8 weeks
Incidence of adverse events
Time Frame: 8 weeks
Proportion of participants that developed a serious side effect in the two arms during the clinical trial.
8 weeks

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Khulood F Alhakami, M.B.B.CH, Assiut University

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 (Anticipated)

June 15, 2022

Primary Completion (Anticipated)

June 15, 2023

Study Completion (Anticipated)

August 15, 2023

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGMW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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