Clinical trial NCT04288817: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Common Wart
Keywords: wart
Intralesional tuberculin PPD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. A dults older than 18 years
2. multiple (\>3 warts) common warts .
3. not currently using other treatments for a wart .
4. not had relapsed at least once after treatment with any of the tissue-destructive modalities.
5. 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.

Primary outcomes:
measure: Size of lesions
timeFrame: Two months
measure: Number of lesions
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: