Anogenital Human Papilloma Virus InfectionPhase 2NCT06809777
Comparison Between Efficacy of Topical 25%Podophyllin and Cryotherapy on Genital Warts
A Phase 2 study testing Topical 25% podophyllin and Cryotherapy in people with Anogenital Human Papilloma Virus Infection, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial summary
Human papilloma virus (HPV), is the major prevalent cause of sexually transmitted disease affecting genitalia, causing Condylomata Accuminata, also known as external genital warts or anogenital warts.¹ Occurring in men and women with a prevalence rate of 0.6-1.2% worldwide. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Anogenital Human Papilloma Virus Infection
- What is being tested?
- Topical 25% podophyllin and Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jun 2025to 10 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 16-60years
- Gender: Any gender
- All new clinically diagnosed cases of plane warts
- Type of warts: plane warts
- Area: Ano-genital warts
- Size: Less than 10cm2(cummulative)
- No. of warts: Upto 20
- Duration of disease: Any
Who cannot join
- Pregnancy and lactating females
- Bleeding disorders
- Immunocompromised patients.
- Diabetic patients / Peripheral vascular disease.
- Bleeding warts, moles, birthmarks.
- Any other inflammatory dermatosis on that area
Show all 9Show fewer
- History of any previous treatment in last 2 months.
- Liver/Renal disease
- Hypersensitivity to Podophyllin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Sheikh zayed Medical College and Hospital
Rahim Yar Khan, Punjab Province, 64200
About this study
Official title: Comparison Between the Efficacy and Safety of Topical Podophyllin 25% Versus Cryotherapy in the Treatment of Anogenital Warts
Human papilloma virus (HPV), is the major prevalent cause of sexually transmitted disease affecting genitalia, causing Condylomata Accuminata, also known as external genital warts or anogenital warts.¹ Occurring in men and women with a prevalence rate of 0.6-1.2% worldwide. It primarily affects those in the age range of 20-25 years. Human papilloma virus infections subclinically are primarily caused by either type HPV- 6 or HPV- 11.
A vast variety of treatment options are available to treat CA , including immunomodulators ( imiquimod, purified protein derivative and the HPV vaccine), physical ablation ( cryotherapy and electrodessication) and topical cytotoxic drugs ( TCA, phenol, 5- fluorouracil, retinoids, podophyllin and bleomycin)¹ . Although there are multiple effective treatment are present for EGW, no single treatment has been identified as the best ideal way to treat CA.
Read more
Cryotherapy causes the destruction of keratinocytes infected with HPV by using below zero temperature and leading to thermal cell necrosis.
Podophyllum peltatum and Podophyllum emodi are the main source of Podophyllin, a refined plant- based resin.¹² It works by attaching itself to the infected cell's microtubule disturbing the linking process which stops the mitotic process during the metaphase stage of cell division causing the death of epithelial cell.
Study will include patients which will be divided into 2 groups A \& B, 48 in each group. Group A will receive topical 25% podophyllin resin via cotton bud under supervision once weekly for 04 weeks. Group B will receive cryotherapy of 10sec freeze cycle twice weekly for 04 weeks. Patient will be followed at interval of 4 weeks and 8 weeks from start of treatment.
Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits. Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30% clearance.
Read the detailed description
Human papilloma virus (HPV), is the major prevalent cause of sexually transmitted disease affecting genitalia, causing Condylomata Accuminata, also known as external genital warts or anogenital warts. Occurring in men and women with a prevalence rate of 0.6-1.2% worldwide. It primarily affects those in the age range of 20-25 years. Human papilloma virus infections subclinically are primarily caused by either type HPV- 6 or HPV- 11.Topical medicines, surgeries and other treatment are among the many possible therapeutic options available. However recurrence and treatment failure are observed with almost all the available treatment after the warts have been visibly cleared.
EGW management poses a major obstacle therapeutically . The patient's immunological condition determine the outcome of the warts , if they are left untreated , they could go away spontaneously, get bigger in size and numerous , or remain the same. The treatment goal is to remove visible warts in order to potentially reduce their infectious , if not the carcinogenic properties.
In this study we will compare the efficacy of topical 25% podophyllin resin versus cryotherapy for the treatment of warts .
Study will include patients which will be divided into 2 groups A \& B, 48 in each group. Group A will receive topical 25% podophyllin resin via cotton bud under supervision once weekly for 04 weeks. Group B will receive cryotherapy of 10sec freeze cycle twice weekly for 04 weeks. Patient will be followed at interval of 4 weeks and 8 weeks from start of treatment.
Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits. Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30% clearance.
- Being tested
- Topical 25% podophyllin, Cryotherapy
- Keywords
- Anogenital warts, Topical 25% podophyllin, cryotherapy
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical 25% podophyllinDrug
25% podophyllin applied topically once weekly for 4 weeks
CryotherapyProcedure or surgery
cryotherapy of 10 sec freeze cycle applied twice weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 25% podophyllin in treatment of anogenital warts ( Group A ) | Active comparator | 25% podophyllin resin will be applied topically once weekly for 4 weeks Receives: Drug: Topical 25% podophyllin |
| cryotherapy for anogenital warts( Group B) | Active comparator | cryotherapy of 10 seconds freeze cycle twice weekly for 04 weeks Receives: Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30
Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits at 4 weeks and 8 weeks after the start of treatment. Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30% clearance.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start29 Jun 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anogenital Human Papilloma Virus InfectionStudies 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Narjis Batool, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809777
- Sponsor's protocol ID
- SheikhZyMC
- Status last verified
- Mar 2025
- First submitted
- 30 Jan 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Efficacy and Safety of Topical Podophyllin 25% Versus Cryotherapy in the Treatment of Anogenital Warts
- ClinicalTrials.gov ID
- NCT06809777
- Acronym / sponsor ID
- SheikhZyMC
- Keywords
- Anogenital warts, Topical 25% podophyllin, cryotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 29 Jun 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 5 Feb 2025 (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.
Human papilloma virus (HPV), is the major prevalent cause of sexually transmitted disease affecting genitalia, causing Condylomata Accuminata, also known as external genital warts or anogenital warts.¹ Occurring in men and women with a prevalence rate of 0.6-1.2% worldwide. It primarily affects those in the age range of 20-25 years. Human papilloma virus infections subclinically are primarily caused by either type HPV- 6 or HPV- 11.
A vast variety of treatment options are available to treat CA , including immunomodulators ( imiquimod, purified protein derivative and the HPV vaccine), physical ablation ( cryotherapy and electrodessication) and topical cytotoxic drugs ( TCA, phenol, 5- fluorouracil, retinoids, podophyllin and bleomycin)¹ . Although there are multiple effective treatment are present for EGW, no single treatment has been identified as the best ideal way to treat CA.
Cryotherapy causes the destruction of keratinocytes infected with HPV by using below zero temperature and leading to thermal cell necrosis.
Podophyllum peltatum and Podophyllum emodi are the main source of Podophyllin, a refined plant- based resin.¹² It works by attaching itself to the infected cell's microtubule disturbing the linking process which stops the mitotic process during the metaphase stage of cell division causing the death of epithelial cell.
Study will include patients which will be divided into 2 groups A \& B, 48 in each group. Group A will receive topical 25% podophyllin resin via cotton bud under supervision once weekly for 04 weeks. Group B will receive cryotherapy of 10sec freeze cycle twice weekly for 04 weeks. Patient will be followed at interval of 4 weeks and 8 weeks from start of treatment.
Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits. Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30% clearance.
Detailed description
Human papilloma virus (HPV), is the major prevalent cause of sexually transmitted disease affecting genitalia, causing Condylomata Accuminata, also known as external genital warts or anogenital warts. Occurring in men and women with a prevalence rate of 0.6-1.2% worldwide. It primarily affects those in the age range of 20-25 years. Human papilloma virus infections subclinically are primarily caused by either type HPV- 6 or HPV- 11.Topical medicines, surgeries and other treatment are among the many possible therapeutic options available. However recurrence and treatment failure are observed with almost all the available treatment after the warts have been visibly cleared.
EGW management poses a major obstacle therapeutically . The patient's immunological condition determine the outcome of the warts , if they are left untreated , they could go away spontaneously, get bigger in size and numerous , or remain the same. The treatment goal is to remove visible warts in order to potentially reduce their infectious , if not the carcinogenic properties.
In this study we will compare the efficacy of topical 25% podophyllin resin versus cryotherapy for the treatment of warts .
Study will include patients which will be divided into 2 groups A \& B, 48 in each group. Group A will receive topical 25% podophyllin resin via cotton bud under supervision once weekly for 04 weeks. Group B will receive cryotherapy of 10sec freeze cycle twice weekly for 04 weeks. Patient will be followed at interval of 4 weeks and 8 weeks from start of treatment.
Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits. Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30% clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25% podophyllin in treatment of anogenital warts ( Group A ) | Active comparator | Drug: Topical 25% podophyllin25% podophyllin resin will be applied topically once weekly for 4 weeks |
| cryotherapy for anogenital warts( Group B) | Active comparator | Procedure: Cryotherapycryotherapy of 10 seconds freeze cycle twice weekly for 04 weeks |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age: 16-60years
- Gender: Any gender
- All new clinically diagnosed cases of plane warts
- Type of warts: plane warts
- Area: Ano-genital warts
Key exclusion criteria (9 listed)
- Pregnancy and lactating females
- Bleeding disorders
- Immunocompromised patients.
- Diabetic patients / Peripheral vascular disease.
- Bleeding warts, moles, birthmarks.
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 |
|---|---|---|
| Topical 25% podophyllin25% podophyllin applied topically once weekly for 4 weeks | Drug | 25% podophyllin in treatment of anogenital warts ( Group A ) |
| Cryotherapycryotherapy of 10 sec freeze cycle applied twice weekly for 4 weeks | Procedure or surgery | cryotherapy for anogenital warts( Group B) |
Primary outcome
Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30
Time frame: 6 months
Treatment will be considered efficant when decrease in the number of warts is clinically evident at follow up visits at 4 weeks and 8 weeks after the start of treatment. Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30% clearance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- 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.
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 Topical 25% podophyllin and Cryotherapy in people with Anogenital Human Papilloma Virus Infection, run by Sheikh Zayed Medical College 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 13 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Narjis Batool, Post graduate resident (+923042937478, drnarjis99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment will be graded as 'excellent' >90% clearance, 'good'60-89% clearance, 'satisfactory'30-59% clearance and 'poor'<30 (time frame: 6 months). 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 13 May 2025.