Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Cryotherapy Combined With Intralesional Tuberculin Purified Protein Derivative (PPD) Versus Interlesional Tuberculin PPD Monotherapy in the Treatment of Multiple Common Warts

Conditions
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Common Wart

Intervention / Treatment
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* Biological: Tuberculin purified protein derivative


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryotherapy and intralesional tuberculin PPD<br>Efficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts | Biological: Tuberculin purified protein derivative<br>* Intralesional injection of tuberculin PPD in treatment of multiple common warts<br>|
| Active Comparator: Intralesional tuberculin PPD<br>Efficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts | Biological: Tuberculin purified protein derivative<br>* Intralesional injection of tuberculin PPD in treatment of multiple common warts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of lesions | By decreasing in size after treatment and compare the response of the lesions tow treatment lines | Two months | 
| 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 | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wart, Intralesional tuberculin PPD