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

NCT ID: NCT04288817

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-05-01

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.

Conditions

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Common Wart

Keywords

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wart Intralesional tuberculin PPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryotherapy and intralesional tuberculin PPD

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

Group Type ACTIVE_COMPARATOR

Tuberculin purified protein derivative

Intervention Type BIOLOGICAL

Intralesional injection of tuberculin PPD in treatment of multiple common warts

Intralesional tuberculin PPD

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

Group Type ACTIVE_COMPARATOR

Tuberculin purified protein derivative

Intervention Type BIOLOGICAL

Intralesional injection of tuberculin PPD in treatment of multiple common warts

Interventions

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Tuberculin purified protein derivative

Intralesional injection of tuberculin PPD in treatment of multiple common warts

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Hiba A H alshaaby

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hiba Abdullah

Role: CONTACT

Phone: 01021432461

Email: [email protected]

References

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Awad SM, Gomaa AS, Hassan HA, Tawfik YM. Efficacy of Cryotherapy Combined With Intralesional Purified Protein Derivative (PPD) Versus Intralesional PPD Monotherapy in the Treatment of Multiple Common Warts. J Cutan Med Surg. 2023 Mar-Apr;27(2):117-125. doi: 10.1177/12034754231152224. Epub 2023 Jan 27.

Reference Type DERIVED
PMID: 36705474 (View on PubMed)

Other Identifiers

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Multiple common warts

Identifier Type: -

Identifier Source: org_study_id