WartsPhase 4NCT03477448
The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts
A Phase 4 study testing Bleomycin and Purified Protein Derivative in people with Warts, run by Assiut University.
Trial summary
Warts are common viral infections on the skin and are prevalent worldwide. Warts are caused by the human Papilloma virus (HPV), which has more than 100 strains; some of them are known to be premalignant. Although warts can appear at any age, they are more common in children and adolescents. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Warts
- What is being tested?
- Bleomycin and Purified Protein Derivative
- Type of treatment
- Vaccines, 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 Apr 2018to 1 Apr 2020
- Phase
- Phase 4
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with positive tuberculin test or with past history of PPD vaccination will include.
- Patient with normal CBC , liver function and renal function
Who cannot join
- Patients with immunosuppression, pregnancy, or lactation, with negative tuberculin test or with past history of tuberculosis, peripheral vascular disease, any abnormality in liver or renal function and those who received any wart treatment 1 month before the start of the study will exclude.
About this study
- Warts are common viral infections on the skin and are prevalent worldwide. Warts are caused by the human Papilloma virus (HPV), which has more than 100 strains; some of them are known to be premalignant. Although warts can appear at any age, they are more common in children and adolescents. The prognosis of warts cannot be predicted. In some patients they may spontaneously disappear, whereas others show persistence and progression with spreading to other body sites, leading to physical and emotional distress to the patients.
- Factors that increase the risk include use of public showers, working with meat, eczema, and a low immune system . The virus is believed to enter the body through skin that has been damaged slightly . A number of types exist including: common warts, plantar warts, filiform warts, and genital warts . Genital warts are often sexually transmitted.
Read the detailed description
- Selection of the most appropriate means of treatment is usually difficult because of the availability of various therapeutic lines and also due to the variability in the immune status of the patients for treatment of warts.
- There are on two main therapeutic options: the first is the conventional destructive and aggressive method, which includes treatment with chemical cautery, cryo- therapy, electro cauterization, surgical excision, and laser ablation . This method depends on destruction of the area of epidermis infected with the virus. The recurrence rates after these therapy modalities maybe high. The second is the immunotherapy, which is based on the activation of the immune system to deal with the virus and suppress its activity. Such therapy may be applied either topically or through intra- lesional injection or through systemic administration .
- Intra-lesional immunotherapy utilizes the ability of the immune system to mount a delayed-type hypersensitivity response to various antigens and also the wart tissue. This therapy has been found to be associated with the production of Th1 cytokines that activate cytotoxic and natural killer cells to eradicate HPV infection. This clears not only the local warts but also distant warts, unlike traditional wart therapies .
- Many authors have used different immunotherapeutic agents for intralesional injection. These include Candida antigen, mumps antigen, trichophytin skin test antigen, BCG vaccine, measles, mumps, and rubella (MMR) vaccine, Mycobacterium w (Mw) vaccine, and IFN-α and IFN-γ injectio).
- Bleomycin, an antibiotic derived from Streptomyces verticillus, has an antitumor, antibacterial, and antiviral activity that may be related to its ability to bind with DNA, causing bleomycin strand scission and elimination of pyrimidine and purine bases. The bleomycin hydrolase enzyme, which is known to inactivate bleomycin, is normally found in all body tissues but is present in very small amounts in skin.
- Intra-lesional bleomycin injection (IBI) has been used for the treatment of warts. Numerous reports have been published on the use of intra-lesional bleomycin for the treatment of recalcitrant warts with cure rates ranging from 14 to 99%. It was found to be very effective in treating warts particularly in periungual and palmoplantar areas .
- No systemic side effects have been observed. However, local signs such as necrosis, pain, scaring, pigment change, Raynaud's phenomenon, and nail dystrophy may occur in some cases.
- Purified protein derivative (PPD) is an extract of Mycobacterium tuberculosis and is used for testing exposure to tuberculin protein, either from a previous vaccination or from the environment. It contains live, attenuated Mycobacterium bovis.
- Using this protein derivative for immunotherapy of warts is important for two major aspects. First, because the obligatory immunization program in many developing countries - with high prevalence of wart in many of them - includes BCG vaccination. PPD has a high prevalence of immunity in the general population. Second, although immunotherapy is generally an inexpensive method of treatment in wart patients, PPD, among conventionally used antigens, is the cheapest.
- IL purified protein derivative (PPD) injection is an acceptable and safe modality in the treatment of warts with complete response in 75% of patients.
- Conditions
- Warts
- Being tested
- Bleomycin, Purified Protein Derivative
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BleomycinDrug
an antibiotic derived from Streptomyces verticillus, has an antitumor, antibacterial, and antiviral activity that may be related to its ability to bind with DNA, causing bleomycin strand scission and elimination of pyrimidine and purine bases. The bleomycin hydrolase enzyme, which is known to inactivate bleomycin, is normally found in all body tissues but is present in very small amounts in skin .
- Intra-lesional bleomycin injection (IBI) has been used for the treatment of warts.
Purified Protein DerivativeDrug
is an extract of Mycobacterium tuberculosis and is used for testing exposure to tuberculin protein, either from a previous vaccination or from the environment. It contains live, attenuated Mycobacterium bovis.
- Using this protein derivative for immunotherapy of warts is important for two major aspects. First, because the obligatory immunization program in many developing countries - with high prevalence of wart in many of them - includes BCG vaccination. PPD has a high prevalence of immunity in the general population. Second, although immunotherapy is generally an inexpensive method of treatment in wart patients, PPD, among conventionally used antigens, is the cheapest
| Study group | Role | What they receive |
|---|---|---|
| PPD group | Active comparator | This group will include 20 patients who will be treated with IL injection of PPD at a dose of 10 IU (0.1 ml) supplied an insulin syringe in the largest wart.
Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions Receives: Drug: Purified Protein Derivative |
| Bleomycin group | Active comparator | This group will include 20 patients who will be treated with IL injection of bleomycin.
Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions, if needed. Receives: Drug: Bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cure rate of patients
the clinical disappearance of the warts
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WartsStudies 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 4
- Primary purpose
- Screening
- 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, Mariem Refaat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477448
- Sponsor's protocol ID
- Bleomycin Vs PPD
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lynch MD, Cliffe J, Morris-Jones R. Management of cutaneous viral warts. BMJ. 2014 May 27;348:g3339. doi: 10.1136/bmj.g3339. No abstract available.
PubMed 24865780Yamamoto T. Bleomycin and the skin. Br J Dermatol. 2006 Nov;155(5):869-75. doi: 10.1111/j.1365-2133.2006.07474.x.
PubMed 17034512
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts
- ClinicalTrials.gov ID
- NCT03477448
- Acronym / sponsor ID
- Bleomycin Vs PPD
- Conditions
- Warts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 26 Mar 2018 (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.
- Warts are common viral infections on the skin and are prevalent worldwide. Warts are caused by the human Papilloma virus (HPV), which has more than 100 strains; some of them are known to be premalignant. Although warts can appear at any age, they are more common in children and adolescents. The prognosis of warts cannot be predicted. In some patients they may spontaneously disappear, whereas others show persistence and progression with spreading to other body sites, leading to physical and emotional distress to the patients.
- Factors that increase the risk include use of public showers, working with meat, eczema, and a low immune system . The virus is believed to enter the body through skin that has been damaged slightly . A number of types exist including: common warts, plantar warts, filiform warts, and genital warts . Genital warts are often sexually transmitted.
Detailed description
- Selection of the most appropriate means of treatment is usually difficult because of the availability of various therapeutic lines and also due to the variability in the immune status of the patients for treatment of warts.
- There are on two main therapeutic options: the first is the conventional destructive and aggressive method, which includes treatment with chemical cautery, cryo- therapy, electro cauterization, surgical excision, and laser ablation . This method depends on destruction of the area of epidermis infected with the virus. The recurrence rates after these therapy modalities maybe high. The second is the immunotherapy, which is based on the activation of the immune system to deal with the virus and suppress its activity. Such therapy may be applied either topically or through intra- lesional injection or through systemic administration .
- Intra-lesional immunotherapy utilizes the ability of the immune system to mount a delayed-type hypersensitivity response to various antigens and also the wart tissue. This therapy has been found to be associated with the production of Th1 cytokines that activate cytotoxic and natural killer cells to eradicate HPV infection. This clears not only the local warts but also distant warts, unlike traditional wart therapies .
- Many authors have used different immunotherapeutic agents for intralesional injection. These include Candida antigen, mumps antigen, trichophytin skin test antigen, BCG vaccine, measles, mumps, and rubella (MMR) vaccine, Mycobacterium w (Mw) vaccine, and IFN-α and IFN-γ injectio).
- Bleomycin, an antibiotic derived from Streptomyces verticillus, has an antitumor, antibacterial, and antiviral activity that may be related to its ability to bind with DNA, causing bleomycin strand scission and elimination of pyrimidine and purine bases. The bleomycin hydrolase enzyme, which is known to inactivate bleomycin, is normally found in all body tissues but is present in very small amounts in skin.
- Intra-lesional bleomycin injection (IBI) has been used for the treatment of warts. Numerous reports have been published on the use of intra-lesional bleomycin for the treatment of recalcitrant warts with cure rates ranging from 14 to 99%. It was found to be very effective in treating warts particularly in periungual and palmoplantar areas .
- No systemic side effects have been observed. However, local signs such as necrosis, pain, scaring, pigment change, Raynaud's phenomenon, and nail dystrophy may occur in some cases.
- Purified protein derivative (PPD) is an extract of Mycobacterium tuberculosis and is used for testing exposure to tuberculin protein, either from a previous vaccination or from the environment. It contains live, attenuated Mycobacterium bovis.
- Using this protein derivative for immunotherapy of warts is important for two major aspects. First, because the obligatory immunization program in many developing countries - with high prevalence of wart in many of them - includes BCG vaccination. PPD has a high prevalence of immunity in the general population. Second, although immunotherapy is generally an inexpensive method of treatment in wart patients, PPD, among conventionally used antigens, is the cheapest.
- IL purified protein derivative (PPD) injection is an acceptable and safe modality in the treatment of warts with complete response in 75% of patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPD group | Active comparator | Drug: Purified Protein DerivativeThis group will include 20 patients who will be treated with IL injection of PPD at a dose of 10 IU (0.1 ml) supplied an insulin syringe in the largest wart. Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions |
| Bleomycin group | Active comparator | Drug: BleomycinThis group will include 20 patients who will be treated with IL injection of bleomycin. Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions, if needed. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with positive tuberculin test or with past history of PPD vaccination will include.
- Patient with normal CBC , liver function and renal function
Key exclusion criteria (1 listed)
- Patients with immunosuppression, pregnancy, or lactation, with negative tuberculin test or with past history of tuberculosis, peripheral vascular disease, any abnormality in liver or renal function and those who received any wart treatment 1 month before the start of the study will exclude.
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 |
|---|---|---|
| Bleomycinan antibiotic derived from Streptomyces verticillus, has an antitumor, antibacterial, and antiviral activity that may be related to its ability to bind with DNA, causing bleomycin strand scission and elimination of pyrimidine and purine bases. The bleomycin hydrolase enzyme, which is known to inactivate bleomycin, is normally found in all body tissues but is present in very small amounts in skin . * Intra-lesional bleomycin injection (IBI) has been used for the treatment of warts. | Drug | Bleomycin group |
| Purified Protein Derivativeis an extract of Mycobacterium tuberculosis and is used for testing exposure to tuberculin protein, either from a previous vaccination or from the environment. It contains live, attenuated Mycobacterium bovis. * Using this protein derivative for immunotherapy of warts is important for two major aspects. First, because the obligatory immunization program in many developing countries - with high prevalence of wart in many of them - includes BCG vaccination. PPD has a high prevalence of immunity in the general population. Second, although immunotherapy is generally an inexpensive method of treatment in wart patients, PPD, among conventionally used antigens, is the cheapest | Drug | PPD group |
Primary outcome
The cure rate of patients
Time frame: One year
the clinical disappearance of the warts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Background: PubMed 24865780Lynch MD, Cliffe J, Morris-Jones R. Management of cutaneous viral warts. BMJ. 2014 May 27;348:g3339. doi: 10.1136/bmj.g3339. No abstract available.
- Background: PubMed 17034512Yamamoto T. Bleomycin and the skin. Br J Dermatol. 2006 Nov;155(5):869-75. doi: 10.1111/j.1365-2133.2006.07474.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bleomycin and Purified Protein Derivative in people with Warts, 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 2 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 26 Mar 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cure rate of patients (time frame: One year). 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 NCT03477448, which also lists 2 linked publications.
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 26 Mar 2018.