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The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional Acyclovir | Experimental | Intralesional acyclovir will be prepared by diluting 1 ampoule of Acyclovir 250mg into 3.5ml of saline solution to achieve a concentration of approximately 70mg/ml. Then 0.1ml will be injected intra-lesionally into the base of the wart. Any hyperkeratotic lesions should be pared before the treatment. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early. |
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| Cryotherapy | Active Comparator | Patients allocated to Group B will undergo cryotherapy using a liquid nitrogen spray gun. Any hyperkeratotic lesions should be pared before the treatment. Two freeze-thaw cycles will be applied each session, the spray gun should be held 1cm away from the wart and maintained until the wart and the 1-3mm of surrounding skin shows freezing, and each cycle should last 15 seconds. Next, the lesion will be left to thaw completely before starting the second cycle. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional Acyclovir | Drug | Intralesional Acyclovir in plantar warts |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate | Number of patients healed after completion of the sessions | 10 weeks (5 sessions max) |
| Recurrence rate | Number of patients had recurred plantar warts after receiving the treatment | 24 weeks |
| Patient satisfaction score | Patient satisfaction questionnaire score | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of treatment with number of ipsilateral warts | Number of warts increased, decreased or stationary | 10 weeks |
| Correlation of treatment with age | Percentage of patients successfully treated in each age group (Young 18-32 years; Middle age 33-46, Old age 47-60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Basant Helal, MRCP | Contact | +201144166922 | basant_helal@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shahira Ramadan, Professor | Cairo University | Study Chair |
| Yousra Azzazi, Lecturer | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospital | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34412535 | Background | Elsayed A, Nassar A, Marei A, Hoseiny HAM, Alakad R. Intralesional Acyclovir: A Potential Therapeutic Option for Cutaneous Warts. J Cutan Med Surg. 2022 Jan-Feb;26(1):25-30. doi: 10.1177/12034754211037998. Epub 2021 Aug 19. | |
| 35365922 | Background | Garcia-Oreja S, Alvaro-Afonso FJ, Tardaguila-Garcia A, Lopez-Moral M, Garcia-Madrid M, Lazaro-Martinez JL. Efficacy of cryotherapy for plantar warts: A systematic review and meta-analysis. Dermatol Ther. 2022 Jun;35(6):e15480. doi: 10.1111/dth.15480. Epub 2022 Apr 6. |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Cryotherapy |
| Device |
Cryotherapy of plantar warts |
|
| 10 weeks |
| Correlation of treatment with gender | Percentage of successfully treated male to female patients | 10 weeks |
| Correlation of treatment with size of the wart | Percentage of successful treatment compared to the size of the wart | 10 weeks |