search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Warts focused on measuring Warts,Laser,Cryotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with common warts male or females any age.
  2. Patient is able to read and understand English and will give written informed consent to participate.
  3. Patient elects to undergo carbon dioxide laser therapy or cryotherapy for treatment of common warts.
  4. Warts to be treated will be located only on the hands.

Exclusion Criteria:

  1. Non cooperative patients.
  2. Patients on other lines of treatment.
  3. Pregnant and lactating females.
  4. Patients receiving topical treatment in the previous two weeks.
  5. 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

    First Posted
    May 23, 2017
    Last Updated
    May 23, 2017
    Sponsor
    Assiut University
    search

    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

    Learn more about this trial

    Carbon Dioxide Laser and Cryotherapy in Treatment of Warts

    We'll reach out to this number within 24 hrs