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Clinical Trials/NCT05300009
NCT05300009UnknownNot Applicable

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

Assiut University0 sites68 target enrollmentStarted: June 15, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
68
Primary Endpoint
Partial resolution

Study Overview

Brief Summary

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.

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 .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 .

Outcomes

Primary Outcomes

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

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.

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khulood Fadhl Ahmed Alhakami

principal investigator

Assiut University

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