the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.

Assiut University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Warts

Treatments: Drug: Salicylic Acid; Device: microneedling; Drug: Ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT07396714

ivermectin for cutaneous warts

Details and patient eligibility

About

To compare between the efficacy and safety of topical ivermectin alone, microneedling with topical ivermectin and topical salicylic acid in treatment of cutaneous warts.

topical ivermectin 1% will be applied on warts whole night clinical assessment will be done every 2 weeks

Microneedling will be performed on the lesion using a microneedling pen type device with a 1-cm tip diameter at a 2-mm depth setting for 2-3 minutes until pinpoint bleebing occurs 1 mL of topical ivermectin 1% will be applied on to the wart tissue.

Sessions: Sessions will be performed every 2 weeks until complete cure or for maximum 6 sessions (total 3 month)

Full description

Wart is a benign skin growth caused by infection with the human papillomavirus (HPV). These lesions typically appear as rough, raised projections on the skin, often on the hands, feet, or other areas. More than 200 types of HPV have been identified.

Worldwide, warts (due to HPV) are extremely common. Estimates suggest about 7-12% of the global population have cutaneous warts at any given time, and among school-aged children the prevalence can reach 10-20%.

The main types of cutaneous non genital warts are : Common warts, often appears on hands &fingers ,Plantar warts: occur on the soles of the feet, Flat warts occur often on the face, legs.

Warts cause pain (especially plantar types), cosmetic embarrassment, in addition to risk of transmission to others There are several therapeutic modalities for warts: include destructive agents (keratolytics, cryotherapy, curettage and cautery, laser, photodynamic therapy), antimitotic agents (podophyllin, bleomycin, retinoids), immune stimulants (topical sensitizers, cimetidine), and topical virucidal agents (formaldehyde, glutaraldehyde) No single treatment is effective in most of patients, available options often painful ,associated with recurrence and have risks like scarring or infection.

Ivermectin, which is traditionally used as an anti- helminthic agent, has been found to have a range of effects beyond its initial well known anti-parasitic use, that include: immune modulatory, anti-viral and anti- proliferative effect. The immune modulatory effect of Ivermectin depends on it's ability to modulate pro-inflammatory cytokines. It also has antiviral role by inhibition of viral replication, several studies have addressed its antiviral activity against a diverse range of viruses, leading to its exploration for use in treating SARS-CoV-2 during the most recent global pandemic .

Emerging literature highlights the potential use of ivermectin as a promising candidate for anticancer therapy through inhibition of the proliferation of the tumour cells by regulating multiple signalling pathways.

In dermatology topical ivermectin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hair lice & rosacea.

The anti-proliferative & antiviral activity of ivermectin suggests it's use in the treatment of HPV infection. Oral ivermectin demonstrated efficacy in a case study for treatment of resistant cutaneous warts, 10 patients clinically diagnosed cutaneous warts were enrolled. Each patient received oral ivermectin at a dose of 200 μg/kg body weight once daily for 3 weeks .Results indicated a substantial reduction in the number and size of warts in 8 patients, 4 patients of them experienced complete resolution of their warts. The efficacy of topical ivermectin in treatment of cutaneous warts still uncovered.

Microneedling is also an effective treatment option for HPV by Immune activation: Micro-injuries initiate a localized inflammatory and wound-healing response, which can enhance the immune system's ability to recognize and clear human papillomavirus (HPV)-infected cells. It also enhance drug penetration: When paired with topical agents (e.g., bleomycin, 5 fluorouracil, methotrexate), microneedling facilitates deeper and more uniform penetration into the wart tissue. This increases drug effectiveness while potentially reducing systemic side effects.

This study will be conducted to explore the potential efficacy of topical ivermectin 1% either alone or in combination with assist delivery via microneedling in treatment of non genital cutaneous warts.

Enrollment: 88 estimated patients

Sex: All

Ages: 11 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with cutaneous non genital warts aged 11:80 y.
• No concurrent systemic or topical treatment of warts

Exclusion criteria

• Genital warts.

  • Pregnancy and lactation.
  • History of any bleeding, clotting disorder or using anticoagulants
  • Chronic systemic diseases such as chronic renal failure, hepaticinsufficiency, and cardiovascular disorders.
  • patients who received any treatment for warts in the last month before the study.
  • Patients with history of neuropathy or peripheral ischemia.
  • Patients with signs of inflammation or infection.
  • Patients with history of a serious systemic or anaphylactic reaction or allergy to ivermectin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 4 patient groups

topical ivermectin

Experimental group

Treatment:

Drug: Ivermectin

microneedling

Experimental group

Description:

patients with cutaneous warts will be treated with microneedling.

Treatment:

Device: microneedling

microneedling with ivermectin

Experimental group

Description:

patients with cutaneous warts will be treated with topical ivermectin with microneedling.

Treatment:

Drug: Ivermectin

Device: microneedling

topical salicylic acid

Active Comparator group

Description:

patients with cutaneous warts will be treated with topical salicylic acid.

Treatment:

Drug: Salicylic Acid