Carbon Dioxide Laser and Cryotherapy in Treatment of Warts
Primary Purpose
Common Warts
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carbon dioxide laser
Cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Common Warts focused on measuring Warts,Laser,Cryotherapy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Carbon dioxide laser group
Cryotherapy group
Arm Description
(group A): thirty patients will be treated by application of carbon dioxide laser.
(group B): thirty patients will be treated by cryotherapy application.
Outcomes
Primary Outcome Measures
Number and size of the lesions.
Dermoscopic evaluation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03166137
Brief Title
Carbon Dioxide Laser and Cryotherapy in Treatment of Warts
Official Title
Comparative Evaluation of Carbon Dioxide Laser and Cryotherapy by Dermoscopy in Treatment of Viral Wart
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Viral warts are common skin conditions seen in both children and adults. Human papilloma virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. Warts can induce hard, thickened skin, black pinpoints, pain or tenderness with significant morbidity for the patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Warts
Keywords
Warts,Laser,Cryotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carbon dioxide laser group
Arm Type
Experimental
Arm Description
(group A): thirty patients will be treated by application of carbon dioxide laser.
Arm Title
Cryotherapy group
Arm Type
Active Comparator
Arm Description
(group B): thirty patients will be treated by cryotherapy application.
Intervention Type
Device
Intervention Name(s)
Carbon dioxide laser
Intervention Description
Radiation by carbon dioxide laser
Intervention Type
Device
Intervention Name(s)
Cryotherapy
Intervention Description
Device using cooling effect
Primary Outcome Measure Information:
Title
Number and size of the lesions.
Description
Dermoscopic evaluation
Time Frame
Two months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nagwa Essa, PD
Phone
00201280994337
Email
nagwaessa@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan Ahmed, MD
Phone
01064447881
Email
hanan_morsy2003@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27215155
Citation
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.
Results Reference
result
PubMed Identifier
22972052
Citation
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.
Results Reference
result
PubMed Identifier
15168956
Citation
Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004 May 15;69(10):2365-72.
Results Reference
result
PubMed Identifier
18032894
Citation
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.
Results Reference
result
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Carbon Dioxide Laser and Cryotherapy in Treatment of Warts
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