Cutaneous WartsPhase 2NCT05023408
Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts
A Phase 2 study testing Bleomycin Injection and Cryotherapy in people with Cutaneous Warts, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
The purpose of the study was to determine the efficacy of intralesional bleomycin in comparison to cryotherapy on participants having cutaneous warts. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Warts
- What is being tested?
- Bleomycin Injection and Cryotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 30 Jun 2021
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Age18 to 60 years
- Either gender.
- Diagnosed cases of cutaneous warts as per operational definition for > 1 week to 48 weeks.
Who cannot join
- • Previously treated for warts by any methodology, assessed by history and clinically.
- Patients with hypertension, cardiovascular disorder, pregnancy, lactation, vascular diseases, assessed by history, clinically \& by positive autoimmune profile.
- Hypersensitivity to lidocaine.
- No given informed written consent.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to determine the efficacy of intralesional bleomycin in comparison to cryotherapy on participants having cutaneous warts.
Read the detailed description
This study was conducted in the Department of Dermatology of Jinnah Postgraduate Medical Centre, Karachi from January to June 2021 after receiving approval from the institutional ethical and research committee of hospital.
Sample size was calculated through NCSS software. Total of one fifty four non-admitted patients were assigned two study groups with equal sample size of 77 randomly through lottery method. Those patients aged between 18 to 60 years of either gender with cutaneous warts for > 1 week to 48 weeks were included after written informed consent. Patients treated previously for warts by any methodology, with history of vascular disease, immunocompromised, hypertension, cardiovascular disorder, pregnancy, lactation and hypersensitivity to lidocaine were excluded.
All demography, clinical history was recorded by a principal investigator on a predesigned Performa , informed written consent was taken before enrolment.
Group A received intralesional bleomycin 0.1% therapy until the lesion blanched. It was prepared manually by diluting 15 mg powder in 5 ml distilled water and then each ml was further diluted by adding 2ml of 2% lignocaine, double the amount taken from the vial, so that concentration became 1mg/1ml (0.1%). Group B patients were treated with liquid nitrogen with the help of a cotton swab wrapped on a wooden stick and was applied firmly with 01 mm extra healthy skin margin until the lesion blanched.
Follow-up was carried out at 02, 04 and 06 weeks. Both the groups were assessed and compared for efficacy after 6 weeks of therapy. SPSS 23 was used for analyzing data.
- Conditions
- Cutaneous Warts
- Being tested
- Bleomycin Injection, Cryotherapy
- Keywords
- cutaneous warts,intralesional bleomycin,cryotherapy,efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleomycin InjectionDrug
Also called Bleomycin Sulfate
Intralesional Bleomycin used for treatment of cutaneous warts.
CryotherapyProcedure or surgery
Cryotherapy used for comparison of efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Bleomycin | Experimental | Intralesional Bleomycin has been given to palmo plantar warts. Generic name: Bleomycin Dose: 1mg/1ml (0.1%) Frequency: every 2 weekly for 6 weeks. Receives: Drug: Bleomycin Injection |
| Cryotherapy | Experimental | Cryotherapy has been given to palmo plantar warts. Frequency: every 2 weekly for 6 weeks Receives: Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in morphology of cutaneous warts.
There is complete remission of cutaneous warts, assessed clinically
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous WartsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Javaria Rahmatullah, Jinnah Postgraduate Medical Centre
- Investigators
- Rabia Ghafoor, FCPS, Study director, Jinnah Postgraduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023408
- Sponsor's protocol ID
- JinnahPMC
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts
- ClinicalTrials.gov ID
- NCT05023408
- Acronym / sponsor ID
- JinnahPMC
- Conditions
- Cutaneous Warts
- Keywords
- cutaneous warts,intralesional bleomycin,cryotherapy,efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Aug 2021 (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 purpose of the study was to determine the efficacy of intralesional bleomycin in comparison to cryotherapy on participants having cutaneous warts.
Detailed description
This study was conducted in the Department of Dermatology of Jinnah Postgraduate Medical Centre, Karachi from January to June 2021 after receiving approval from the institutional ethical and research committee of hospital.
Sample size was calculated through NCSS software. Total of one fifty four non-admitted patients were assigned two study groups with equal sample size of 77 randomly through lottery method. Those patients aged between 18 to 60 years of either gender with cutaneous warts for > 1 week to 48 weeks were included after written informed consent. Patients treated previously for warts by any methodology, with history of vascular disease, immunocompromised, hypertension, cardiovascular disorder, pregnancy, lactation and hypersensitivity to lidocaine were excluded.
All demography, clinical history was recorded by a principal investigator on a predesigned Performa , informed written consent was taken before enrolment.
Group A received intralesional bleomycin 0.1% therapy until the lesion blanched. It was prepared manually by diluting 15 mg powder in 5 ml distilled water and then each ml was further diluted by adding 2ml of 2% lignocaine, double the amount taken from the vial, so that concentration became 1mg/1ml (0.1%). Group B patients were treated with liquid nitrogen with the help of a cotton swab wrapped on a wooden stick and was applied firmly with 01 mm extra healthy skin margin until the lesion blanched.
Follow-up was carried out at 02, 04 and 06 weeks. Both the groups were assessed and compared for efficacy after 6 weeks of therapy. SPSS 23 was used for analyzing data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional Bleomycin | Experimental | Drug: Bleomycin InjectionIntralesional Bleomycin has been given to palmo plantar warts. Generic name: Bleomycin Dose: 1mg/1ml (0.1%) Frequency: every 2 weekly for 6 weeks. |
| Cryotherapy | Experimental | Procedure: CryotherapyCryotherapy has been given to palmo plantar warts. Frequency: every 2 weekly for 6 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Age18 to 60 years
Key exclusion criteria (4 listed)
- • Previously treated for warts by any methodology, assessed by history and clinically.
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 |
|---|---|---|
| Bleomycin InjectionAlso: Bleomycin SulfateIntralesional Bleomycin used for treatment of cutaneous warts. | Drug | Intralesional Bleomycin |
| CryotherapyCryotherapy used for comparison of efficacy. | Procedure or surgery | Cryotherapy |
Primary outcome
change in morphology of cutaneous warts.
Time frame: 6 weeks
There is complete remission of cutaneous warts, assessed clinically
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Rabia Ghafoor, FCPS study director
Jinnah Postgraduate Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bleomycin Injection and Cryotherapy in people with Cutaneous Warts, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in morphology of cutaneous warts. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2021.