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

Common Wart Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04288817
• Other study ID #: Multiple common warts
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: Hiba Abdullah
• Phone: 01021432461
• Email: hibaalshaaby7[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Common Wart
• Warts

Intervention

Biological:
• Tuberculin purified protein derivative
Intralesional injection of tuberculin PPD in treatment of multiple common warts

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of lesions	By decreasing in size after treatment and compare the response of the lesions tow treatment lines	Two months
Primary	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