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

Assiut University

Status and phase: Unknown; Phase 3

Conditions: Common Wart

Treatments: Biological: Tuberculin purified protein derivative

Study type: Interventional

Funder types: Other

Identifiers

NCT04288817

Multiple common warts

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cryotherapy and intralesional tuberculin PPD

Active Comparator group

Description:

Efficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts

Treatment:

Biological: Tuberculin purified protein derivative

Intralesional tuberculin PPD

Active Comparator group

Description:

Efficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts

Treatment:

Biological: Tuberculin purified protein derivative