- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03166137
Carbon Dioxide Laser and Cryotherapy in Treatment of Warts
Comparative Evaluation of Carbon Dioxide Laser and Cryotherapy by Dermoscopy in Treatment of Viral Wart
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A range of types of wart have been identified, varying in shape and site affected, as well as the type of human papillomavirus involved.
These include:
- Common wart (Verruca vulgaris).
- Flat wart (Verruca plana).
- Filiform or digitate wart.
- Genital wart (venereal wart, Condyloma acuminatum, Verruca acuminata).
- Mosaic wart.
- Periungual wart.
- Plantar wart (verruca, Verruca plantaris). Despite the presence of several therapeutic options, treatment of warts can present a challenge and they are not uniformly effective. Viral warts often disappear without treatment. In case of pain, discomfort and long duration they can be treated . Treatment options include cryotherapy, electrocautery, salicylic acid, immune therapy, minor surgery or laser surgery.
Common warts have a distinctive appearance and can usually be diagnosed with the unaided eye; however, early growth stages and post-treatment warts are less easily diagnosed. Published dermoscopic features of common warts include frogspawn pattern, mosaic pattern and dotted, linear, globular or coiled vessels. Mosaic pattern consists of relatively flattened, rounded structures of similar size, resembling a jigsaw puzzle. Frogspawn pattern consists of densely packed papillae, each containing red dot or loop, surrounded by a whitish halo. Vascular structures seen dermoscopically in common warts as red or black dotted, linear, globular and coiled vessels. Haemorrhages are possible additional features, with black dots corresponding to thrombosed vessels. Hairpin vessels were usually seen in non-wart lesions.
In this study, we aim to compare two therapeutic modalities, the clinical effectiveness and safety of carbon dioxide laser and cryotherapy in the treatment of viral warts together with dermoscopic evaluation of viral warts before and after treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with common warts male or females any age.
- Patient is able to read and understand English and will give written informed consent to participate.
- Patient elects to undergo carbon dioxide laser therapy or cryotherapy for treatment of common warts.
- Warts to be treated will be located only on the hands.
Exclusion Criteria:
- Non cooperative patients.
- Patients on other lines of treatment.
- Pregnant and lactating females.
- Patients receiving topical treatment in the previous two weeks.
- Secondary infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Carbon dioxide laser group
(group A): thirty patients will be treated by application of carbon dioxide laser.
|
Radiation by carbon dioxide laser
|
|
Active Comparator: Cryotherapy group
(group B): thirty patients will be treated by cryotherapy application.
|
Device using cooling effect
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and size of the lesions.
Time Frame: Two months
|
Dermoscopic evaluation
|
Two months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Vlahovic TC, Khan MT. The Human Papillomavirus and Its Role in Plantar Warts: A Comprehensive Review of Diagnosis and Management. Clin Podiatr Med Surg. 2016 Jul;33(3):337-53. doi: 10.1016/j.cpm.2016.02.003. Epub 2016 Mar 29.
- Kwok CS, Gibbs S, Bennett C, Holland R, Abbott R. Topical treatments for cutaneous warts. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD001781. doi: 10.1002/14651858.CD001781.pub3.
- Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004 May 15;69(10):2365-72.
- Zalaudek I, Giacomel J, Cabo H, Di Stefani A, Ferrara G, Hofmann-Wellenhof R, Malvehy J, Puig S, Stolz W, Argenziano G. Entodermoscopy: a new tool for diagnosing skin infections and infestations. Dermatology. 2008;216(1):14-23. doi: 10.1159/000109353.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laser,Cryotherapy,Wart
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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