Common WartPhase 3NCT04288817
Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts
A Phase 3 study testing Tuberculin purified protein derivative in people with Common Wart, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Common Wart
- What is being tested?
- Tuberculin purified protein derivative
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Conditions
- Common Wart
- Being tested
- Tuberculin purified protein derivative
- Keywords
- wart, Intralesional tuberculin PPD
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculin purified protein derivativeBiological
Intralesional injection of tuberculin PPD in treatment of multiple common warts
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy and intralesional tuberculin PPD | Active comparator | Efficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts Receives: Biological: Tuberculin purified protein derivative |
| Intralesional tuberculin PPD | Active comparator | Efficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts Receives: Biological: Tuberculin purified protein derivative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of lesions
By decreasing in size after treatment and compare the response of the lesions tow treatment lines
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common WartStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiba A H alshaaby, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288817
- Sponsor's protocol ID
- Multiple common warts
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36705474
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04288817
- Acronym / sponsor ID
- Multiple common warts
- Conditions
- Common Wart
- Keywords
- wart, Intralesional tuberculin PPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy and intralesional tuberculin PPD | Active comparator | Biological: Tuberculin purified protein derivativeEfficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts |
| Intralesional tuberculin PPD | Active comparator | Biological: Tuberculin purified protein derivativeEfficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuberculin purified protein derivativeIntralesional injection of tuberculin PPD in treatment of multiple common warts | Biological | Cryotherapy and intralesional tuberculin PPD, Intralesional tuberculin PPD |
Primary outcome
Size of lesions
Time frame: Two months
By decreasing in size after treatment and compare the response of the lesions tow treatment lines
Number of lesions
Time frame: 4 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Derived from this study: PubMed 36705474Awad 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tuberculin purified protein derivative in people with Common Wart, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiba Abdullah (01021432461 ext. 0020, hibaalshaaby7@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of lesions (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.