Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts
Primary Purpose
Common Wart
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tuberculin purified protein derivative
Sponsored by
![Assiut University](https://trials-media.s3.amazonaws.com/orgs/assiut-university.jpeg)
About this trial
This is an interventional treatment trial for Common Wart focused on measuring wart, Intralesional tuberculin PPD
Eligibility Criteria
Inclusion Criteria:
- A dults older than 18 years
- multiple (>3 warts) common warts .
- not currently using other treatments for a wart .
- not had relapsed at least once after treatment with any of the tissue-destructive modalities.
- Positive tuberculin skin test.
Exclusion Criteria:
- Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cryotherapy and intralesional tuberculin PPD
Intralesional tuberculin PPD
Arm Description
Efficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts
Efficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts
Outcomes
Primary Outcome Measures
Size of lesions
By decreasing in size after treatment and compare the response of the lesions tow treatment lines
Number of lesions
The following grading system will be used to evaluate treatment response:
*Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings).
Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response.
Moderate response: partial responders show 25 to 75% improvement.
No or minimal response: less than 25% decrease in size/numbers of all warts. the study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04288817
Brief Title
Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts
Official Title
Efficacy of Cryotherapy Combined With Intralesional Tuberculin Purified Protein Derivative (PPD) Versus Interlesional Tuberculin PPD Monotherapy in the Treatment of Multiple Common Warts
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (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
5. Study Description
Brief Summary
The investigate the efficacy and safety of combined 'cryo-immuno-therapy' versus intralesional tuberculin purified protein derivative (PPD) antigen immunotherapy alone for multiple common warts
Detailed Description
Common warts are benign skin lesions caused by the human papillomavirus (HPV). The dorsal surface of the hands and fingers are the main predilection sites. Cryotherapy is frequently used to eradicate common warts via necrotic destruction of HPV-infected keratinocytes or by inducing of an effective cell-mediated immune response. However, the cure rates of cryotherapy are only around (44-47%) .
Intralesional antigen immunotherapy represents a promising therapeutic approach for the treatment of different types of warts, particularly if multiple and/or recalcitrant.
The investigate the efficacy and safety of combined 'cryo-immuno-therapy' versus intralesional tuberculin purified protein n immunotherapy alone for multiple common warts.
Although intralesional immunotherapy - compared to conventional therapeutic methods - has been generally along with better outcome, lower incidence of side effects and less recurrence, it is not still approved as a standard method of treatment in patients with wart , because the majority of available studies are open-labeled and randomized, placebo-controlled trials are very scarce.
The immune system plays an important role in the spontaneous resolution of warts. The immune mechanisms against HPV include the development of cell-mediated immune response with activation of T helper1 (Th1) lymphocytes resulting in long-term immunity . Stimulation of the immune system would clear warts in other locations, eliminating the need for the local treatment for each individual wart .
Multiple studies support the use of intralesional PPD injection as an effective and valuable treatment option due to its systemic effect, especially for patients with multiple warts, with the benefit of clearance of both treated and distant warts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Wart
Keywords
wart, Intralesional tuberculin PPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryotherapy and intralesional tuberculin PPD
Arm Type
Active Comparator
Arm Description
Efficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts
Arm Title
Intralesional tuberculin PPD
Arm Type
Active Comparator
Arm Description
Efficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts
Intervention Type
Biological
Intervention Name(s)
Tuberculin purified protein derivative
Intervention Description
Intralesional injection of tuberculin PPD in treatment of multiple common warts
Primary Outcome Measure Information:
Title
Size of lesions
Description
By decreasing in size after treatment and compare the response of the lesions tow treatment lines
Time Frame
Two months
Title
Number of lesions
Description
The following grading system will be used to evaluate treatment response:
*Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings).
Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response.
Moderate response: partial responders show 25 to 75% improvement.
No or minimal response: less than 25% decrease in size/numbers of all warts. the study
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A dults older than 18 years
multiple (>3 warts) common warts .
not currently using other treatments for a wart .
not had relapsed at least once after treatment with any of the tissue-destructive modalities.
Positive tuberculin skin test.
Exclusion Criteria:
Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiba Abdullah
Phone
01021432461
Ext
0020
Email
hibaalshaaby7@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts
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