Common WartsNCT03166137
Carbon Dioxide Laser and Cryotherapy in Treatment of Warts
A study testing Carbon dioxide laser and Cryotherapy in people with Common Warts, run by Assiut University.
Trial summary
Viral warts are common skin conditions seen in both children and adults. Human papilloma virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Common Warts
- What is being tested?
- Carbon dioxide laser and Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Aug 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with common warts male or females any age.
- Patient is able to read and understand English and will give written informed consent to participate.
- Patient elects to undergo carbon dioxide laser therapy or cryotherapy for treatment of common warts.
- Warts to be treated will be located only on the hands.
Who cannot join
- Non cooperative patients.
- Patients on other lines of treatment.
- Pregnant and lactating females.
- Patients receiving topical treatment in the previous two weeks.
- Secondary infection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation of Carbon Dioxide Laser and Cryotherapy by Dermoscopy in Treatment of Viral Wart
Viral warts are common skin conditions seen in both children and adults. Human papilloma virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. Warts can induce hard, thickened skin, black pinpoints, pain or tenderness with significant morbidity for the patients.
Read the detailed description
A range of types of wart have been identified, varying in shape and site affected, as well as the type of human papillomavirus involved.
These include:
- Common wart (Verruca vulgaris).
- Flat wart (Verruca plana).
- Filiform or digitate wart.
- Genital wart (venereal wart, Condyloma acuminatum, Verruca acuminata).
- Mosaic wart.
- Periungual wart.
- Plantar wart (verruca, Verruca plantaris). Despite the presence of several therapeutic options, treatment of warts can present a challenge and they are not uniformly effective. Viral warts often disappear without treatment. In case of pain, discomfort and long duration they can be treated . Treatment options include cryotherapy, electrocautery, salicylic acid, immune therapy, minor surgery or laser surgery.
Common warts have a distinctive appearance and can usually be diagnosed with the unaided eye; however, early growth stages and post-treatment warts are less easily diagnosed. Published dermoscopic features of common warts include frogspawn pattern, mosaic pattern and dotted, linear, globular or coiled vessels. Mosaic pattern consists of relatively flattened, rounded structures of similar size, resembling a jigsaw puzzle. Frogspawn pattern consists of densely packed papillae, each containing red dot or loop, surrounded by a whitish halo. Vascular structures seen dermoscopically in common warts as red or black dotted, linear, globular and coiled vessels. Haemorrhages are possible additional features, with black dots corresponding to thrombosed vessels. Hairpin vessels were usually seen in non-wart lesions.
In this study, we aim to compare two therapeutic modalities, the clinical effectiveness and safety of carbon dioxide laser and cryotherapy in the treatment of viral warts together with dermoscopic evaluation of viral warts before and after treatment.
- Conditions
- Common Warts
- Being tested
- Carbon dioxide laser, Cryotherapy
- Keywords
- Warts,Laser,Cryotherapy
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide laserDevice
Radiation by carbon dioxide laser
CryotherapyDevice
Device using cooling effect
| Study group | Role | What they receive |
|---|---|---|
| Carbon dioxide laser group | Experimental | (group A): thirty patients will be treated by application of carbon dioxide laser. Receives: Device: Carbon dioxide laser |
| Cryotherapy group | Active comparator | (group B): thirty patients will be treated by cryotherapy application. Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and size of the lesions.
Dermoscopic evaluation
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Common 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadija Yousef Badawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166137
- Sponsor's protocol ID
- Laser,Cryotherapy,Wart
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vlahovic TC, Khan MT. The Human Papillomavirus and Its Role in Plantar Warts: A Comprehensive Review of Diagnosis and Management. Clin Podiatr Med Surg. 2016 Jul;33(3):337-53. doi: 10.1016/j.cpm.2016.02.003. Epub 2016 Mar 29.
PubMed 27215155Kwok CS, Gibbs S, Bennett C, Holland R, Abbott R. Topical treatments for cutaneous warts. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD001781. doi: 10.1002/14651858.CD001781.pub3.
PubMed 22972052Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004 May 15;69(10):2365-72.
PubMed 15168956Zalaudek I, Giacomel J, Cabo H, Di Stefani A, Ferrara G, Hofmann-Wellenhof R, Malvehy J, Puig S, Stolz W, Argenziano G. Entodermoscopy: a new tool for diagnosing skin infections and infestations. Dermatology. 2008;216(1):14-23. doi: 10.1159/000109353.
PubMed 18032894
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Carbon Dioxide Laser and Cryotherapy by Dermoscopy in Treatment of Viral Wart
- ClinicalTrials.gov ID
- NCT03166137
- Acronym / sponsor ID
- Laser,Cryotherapy,Wart
- Conditions
- Common Warts
- Keywords
- Warts,Laser,Cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 25 May 2017 (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.
Viral warts are common skin conditions seen in both children and adults. Human papilloma virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. Warts can induce hard, thickened skin, black pinpoints, pain or tenderness with significant morbidity for the patients.
Detailed description
A range of types of wart have been identified, varying in shape and site affected, as well as the type of human papillomavirus involved.
These include:
- Common wart (Verruca vulgaris).
- Flat wart (Verruca plana).
- Filiform or digitate wart.
- Genital wart (venereal wart, Condyloma acuminatum, Verruca acuminata).
- Mosaic wart.
- Periungual wart.
- Plantar wart (verruca, Verruca plantaris). Despite the presence of several therapeutic options, treatment of warts can present a challenge and they are not uniformly effective. Viral warts often disappear without treatment. In case of pain, discomfort and long duration they can be treated . Treatment options include cryotherapy, electrocautery, salicylic acid, immune therapy, minor surgery or laser surgery.
Common warts have a distinctive appearance and can usually be diagnosed with the unaided eye; however, early growth stages and post-treatment warts are less easily diagnosed. Published dermoscopic features of common warts include frogspawn pattern, mosaic pattern and dotted, linear, globular or coiled vessels. Mosaic pattern consists of relatively flattened, rounded structures of similar size, resembling a jigsaw puzzle. Frogspawn pattern consists of densely packed papillae, each containing red dot or loop, surrounded by a whitish halo. Vascular structures seen dermoscopically in common warts as red or black dotted, linear, globular and coiled vessels. Haemorrhages are possible additional features, with black dots corresponding to thrombosed vessels. Hairpin vessels were usually seen in non-wart lesions.
In this study, we aim to compare two therapeutic modalities, the clinical effectiveness and safety of carbon dioxide laser and cryotherapy in the treatment of viral warts together with dermoscopic evaluation of viral warts before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon dioxide laser group | Experimental | Device: Carbon dioxide laser(group A): thirty patients will be treated by application of carbon dioxide laser. |
| Cryotherapy group | Active comparator | Device: Cryotherapy(group B): thirty patients will be treated by cryotherapy application. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with common warts male or females any age.
- Patient is able to read and understand English and will give written informed consent to participate.
- Patient elects to undergo carbon dioxide laser therapy or cryotherapy for treatment of common warts.
- Warts to be treated will be located only on the hands.
Key exclusion criteria (5 listed)
- Non cooperative patients.
- Patients on other lines of treatment.
- Pregnant and lactating females.
- Patients receiving topical treatment in the previous two weeks.
- Secondary infection.
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 |
|---|---|---|
| Carbon dioxide laserRadiation by carbon dioxide laser | Device | Carbon dioxide laser group |
| CryotherapyDevice using cooling effect | Device | Cryotherapy group |
Primary outcome
Number and size of the lesions.
Time frame: Two months
Dermoscopic evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Results publication: PubMed 27215155Vlahovic TC, Khan MT. The Human Papillomavirus and Its Role in Plantar Warts: A Comprehensive Review of Diagnosis and Management. Clin Podiatr Med Surg. 2016 Jul;33(3):337-53. doi: 10.1016/j.cpm.2016.02.003. Epub 2016 Mar 29.
- Results publication: PubMed 22972052Kwok CS, Gibbs S, Bennett C, Holland R, Abbott R. Topical treatments for cutaneous warts. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD001781. doi: 10.1002/14651858.CD001781.pub3.
- Results publication: PubMed 15168956Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004 May 15;69(10):2365-72.
- Results publication: PubMed 18032894Zalaudek I, Giacomel J, Cabo H, Di Stefani A, Ferrara G, Hofmann-Wellenhof R, Malvehy J, Puig S, Stolz W, Argenziano G. Entodermoscopy: a new tool for diagnosing skin infections and infestations. Dermatology. 2008;216(1):14-23. doi: 10.1159/000109353.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon dioxide laser and Cryotherapy in people with Common 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 4 inclusion and 5 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 25 May 2017. 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.
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 Nagwa Essa, PD (00201280994337, nagwaessa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and size of the lesions. (time frame: Two months). 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 NCT03166137, which also lists 4 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 25 May 2017.