Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts
- Conditions
- Common Wart
- Interventions
- Biological: Tuberculin purified protein derivative
- Registration Number
- NCT04288817
- Lead Sponsor
- Assiut University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryotherapy and intralesional tuberculin PPD Tuberculin purified protein derivative Efficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts Intralesional tuberculin PPD Tuberculin purified protein derivative Efficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts
- Primary Outcome Measures
Name Time Method Number of lesions 4 months 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 studySize of lesions Two months By decreasing in size after treatment and compare the response of the lesions tow treatment lines
- Secondary Outcome Measures
Name Time Method