Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2020
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedFebruary 28, 2020
February 1, 2020
1 year
February 19, 2020
February 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Size of lesions
By decreasing in size after treatment and compare the response of the lesions tow treatment lines
Two months
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
Study Arms (2)
Cryotherapy and intralesional tuberculin PPD
ACTIVE COMPARATOREfficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts
Intralesional tuberculin PPD
ACTIVE COMPARATOREfficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts
Interventions
Intralesional injection of tuberculin PPD in treatment of multiple common warts
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 36705474DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 19, 2020
First Posted
February 28, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2021
Study Completion
May 1, 2021
Last Updated
February 28, 2020
Record last verified: 2020-02