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

ConditionWarts
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age11-80
SponsorAssiut University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with cutaneous non genital warts aged 11:80 y.

No concurrent systemic or topical treatment of warts

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivermectin

    Drug

    patients with non-genital cutaneous warts will be treated by topical application of ivermectin : topical ivermectin 1% will be applied under occlusion overnight daily then revaluated every 2 weeks for maximum 12 weeks

  • microneedling

    Device

    patients with non-genital cutaneous warts will be treated by microneedling (2mm depth) every 2-weeks until complete clearance or for a maximum of 12weeks

  • Salicylic Acid

    Drug

    patients with non-genital cutaneous warts will be treated by topical application of ivermectin : cotton soaked with topical salicylic acid will be applied under occlusion overnight daily then revaluated every 2 weeks for maximum 12 weeks

Treatment groups

88 Participants
are divided into 4 treatment groups
Group A: topical ivermectinExperimental treatment 1 intervention
Group B: microneedlingExperimental treatment 1 intervention
Group C: microneedling with ivermectinExperimental treatment 2 interventions
Group D: topical salicylic acidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

evaluation of the efficacy of topical ivermectin in treatment of cutaneous warts.

clinical assessment of warts at the baseline \& each visit comparing photographs at different timeline .

Time frame
baseline

Secondary outcomes

1

evaluation of the efficacy of topical ivermectin combined with microneedling in treatment of cutaneous warts.

clinical assessment of warts at the baseline \& at each visit every 2 weeks

Time frame
baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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