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Carbon Dioxide Laser and Cryotherapy in Treatment of Warts

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ClinicalTrials.gov Identifier: NCT03166137
Recruitment Status : Unknown
Verified May 2017 by Kadija Yousef Badawy, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Kadija Yousef Badawy, Assiut University

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE May 25, 2017
Last Update Posted Date May 25, 2017
Estimated Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
Number and size of the lesions. [ Time Frame: Two months ]
Dermoscopic evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbon Dioxide Laser and Cryotherapy in Treatment of Warts
Official Title  ICMJE Comparative Evaluation of Carbon Dioxide Laser and Cryotherapy by Dermoscopy in Treatment of Viral Wart
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Common Warts
Intervention  ICMJE
  • Device: Carbon dioxide laser
    Radiation by carbon dioxide laser
  • Device: Cryotherapy
    Device using cooling effect
Study Arms  ICMJE
  • Experimental: Carbon dioxide laser group
    (group A): thirty patients will be treated by application of carbon dioxide laser.
    Intervention: Device: Carbon dioxide laser
  • Active Comparator: Cryotherapy group
    (group B): thirty patients will be treated by cryotherapy application.
    Intervention: Device: Cryotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03166137
Other Study ID Numbers  ICMJE Laser,Cryotherapy,Wart
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kadija Yousef Badawy, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP