Cutaneous WartsPhase 1NCT05739786
Comparisom of Liquid Nitrogen and Vitamin D3 in The Treatment of Cutaneous Warts
A Phase 1 study testing liq nitrogen and intralesional vitamin D3 in people with Cutaneous Warts, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial summary
A total of 60 female patients (30 patients in each group) with cutaneious warts diagnosed by a consultant dermatologist on physical examination were included in this study. In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cutaneous Warts
- What is being tested?
- liq nitrogen and intralesional vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 11 May 2022to 11 Nov 2022
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patient of cutaneous warts presented in dermatology department.
Who cannot join
- Immunosuppressed patients
- chronic skin diseases like eczema or autoimmune disease
- diabetes mellitus
- cold sensitivity , skin allergies
- pregnancy, and lactation
- periungual warts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Liquid Nitrogen Versus Vitamin D3 in The Treatment of Cutaneous Warts
A total of 60 female patients (30 patients in each group) with cutaneious warts diagnosed by a consultant dermatologist on physical examination were included in this study.
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
- Conditions
- Cutaneous Warts
- Being tested
- liq nitrogen, intralesional vitamin D3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liq nitrogenDrug
Also called cryotherapy
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) for 3 sessions at every 3 weeks interval. Effectiveness in was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
intralesional vitamin D3Drug
Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
| Study group | Role | What they receive |
|---|---|---|
| Group A liquid nitrogen | Active comparator | liquid nitrogen In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) for 3 sessions at every 3 weeks interval. Effectiveness in was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission. Receives: Drug: liq nitrogen |
| Group B intralesional Vit D3 | Active comparator | intralesional Vit D3 Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission. Receives: Drug: intralesional vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of liquid nitrogen and intralesional vitamin D3 in treatment of cutaneous warts
For 2nd Article: A total of 60 female patients (30 patients in each group) with cutaneous warts diagnosed by a consultant dermatologist on physical examination were included in this study.
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.Total duration of therapy for each patient will be 9 weeks after "recurrence and remission"
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start11 May 2022
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ilyas, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739786
- Sponsor's protocol ID
- CMHAtd-ETH-17-DERM-22
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Liquid Nitrogen Versus Vitamin D3 in The Treatment of Cutaneous Warts
- ClinicalTrials.gov ID
- NCT05739786
- Acronym / sponsor ID
- CMHAtd-ETH-17-DERM-22
- Conditions
- Cutaneous Warts
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 22 Feb 2023 (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.
A total of 60 female patients (30 patients in each group) with cutaneious warts diagnosed by a consultant dermatologist on physical examination were included in this study.
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A liquid nitrogen | Active comparator | Drug: liq nitrogenliquid nitrogen In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) for 3 sessions at every 3 weeks interval. Effectiveness in was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission. |
| Group B intralesional Vit D3 | Active comparator | Drug: intralesional vitamin D3intralesional Vit D3 Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient of cutaneous warts presented in dermatology department.
Key exclusion criteria (6 listed)
- Immunosuppressed patients
- chronic skin diseases like eczema or autoimmune disease
- diabetes mellitus
- cold sensitivity , skin allergies
- pregnancy, and lactation
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 |
|---|---|---|
| liq nitrogenAlso: cryotherapyIn Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) for 3 sessions at every 3 weeks interval. Effectiveness in was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission. | Drug | Group A liquid nitrogen |
| intralesional vitamin D3Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission. | Drug | Group B intralesional Vit D3 |
Primary outcome
Effectiveness of liquid nitrogen and intralesional vitamin D3 in treatment of cutaneous warts
Time frame: 9 weeks
For 2nd Article: A total of 60 female patients (30 patients in each group) with cutaneous warts diagnosed by a consultant dermatologist on physical examination were included in this study. In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of > 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.Total duration of therapy for each patient will be 9 weeks after "recurrence and remission"
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 22 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing liq nitrogen and intralesional vitamin D3 in people with Cutaneous Warts, run by Combined Military Hospital Abbottabad 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 1 inclusion and 6 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 22 Feb 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Effectiveness of liquid nitrogen and intralesional vitamin D3 in treatment of cutaneous warts (time frame: 9 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 22 Feb 2023.