Verruca VulgarisNCT04620785
Photodynamic Therapy in Treatment of Verrucae
A study testing methylene blue / IPL, IPL and saline in people with Verruca Vulgaris, run by Alexandria University at 1 site in Egypt.
Trial summary
To assess the efficacy (clinically and dermoscopically) and safety of photodynamic therapy using intralesional injection of 4% methylene blue solution as a photosensitizer with IPL versus IPL only in treatment of warts. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Verruca Vulgaris
- What is being tested?
- methylene blue / IPL, IPL and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 May 2022
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age:Above 16 years old.
- Sex:Both males and female patients.
- Clinically and dermoscopically documented verruca.
- No verruca treatment in the last 2 weeks.
Who cannot join
- History of photosensitivity disorder.
- Pregnant and lactating females.
- Diseases with risk of koebnerization e.g. Psoriasis and Lichen planus.
- Anogenital warts.
- Warts on head and neck.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University Faculty of Medicine
Alexandria
amira abulfotooh eid, MD, 01006897449, dramiraeid@yahoo.co.uk
About this study
Official title: PHOTODYNAMIC THERAPY USING METHYLENE BLUE AND INTENSE PULSED LIGHT VERSUS INTENSE PULSED LIGHT ALONE IN TREATMENT OF VERRUCA :A RANDOMIZED CONTROLLED STUDY
To assess the efficacy (clinically and dermoscopically) and safety of photodynamic therapy using intralesional injection of 4% methylene blue solution as a photosensitizer with IPL versus IPL only in treatment of warts.
Read the detailed description
This study will be conducted on:
Eighty patients suffering of verruca (male and female) divided randomly into three groups: group A, B\&C :
Group A: 30 patients will undergo photodynamic therapy using intralesional 4%methylene blue solution and IPL.
Group B: 30 patients will undergo IPL only. Group C (control group):20 patients will undergo intralesional saline.
- Conditions
- Verruca Vulgaris
- Being tested
- methylene blue / IPL, IPL, saline
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylene blue / IPLOther
therapeutic
IPLOther
therapeutic
salineOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| methylene blue/IPL | Experimental | will undergo photodynamic therapy using intralesional 4%methylene blue solution ,after a period of 15 minutes the patient will be subjected to IPL session.
This will be repeated biweekly until complete clearance of the lesion or a maximum four sessions. Receives: Other: methylene blue / IPL |
| IPL | Experimental | will undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions. Receives: Other: IPL |
| saline | Placebo comparator | will undergo intralesional saline. Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
disappearance of verruca
clinical and dermoscopic cure
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Jan 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verruca VulgarisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa eldeeb, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620785
- Sponsor's protocol ID
- 0106171
- Status last verified
- Jul 2021
- First submitted
- 3 Nov 2020
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHOTODYNAMIC THERAPY USING METHYLENE BLUE AND INTENSE PULSED LIGHT VERSUS INTENSE PULSED LIGHT ALONE IN TREATMENT OF VERRUCA :A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT04620785
- Acronym / sponsor ID
- 0106171
- Conditions
- Verruca Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 9 Nov 2020 (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.
To assess the efficacy (clinically and dermoscopically) and safety of photodynamic therapy using intralesional injection of 4% methylene blue solution as a photosensitizer with IPL versus IPL only in treatment of warts.
Detailed description
This study will be conducted on:
Eighty patients suffering of verruca (male and female) divided randomly into three groups: group A, B\&C :
Group A: 30 patients will undergo photodynamic therapy using intralesional 4%methylene blue solution and IPL.
Group B: 30 patients will undergo IPL only. Group C (control group):20 patients will undergo intralesional saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| methylene blue/IPL | Experimental | Other: methylene blue / IPLwill undergo photodynamic therapy using intralesional 4%methylene blue solution ,after a period of 15 minutes the patient will be subjected to IPL session. This will be repeated biweekly until complete clearance of the lesion or a maximum four sessions. |
| IPL | Experimental | Other: IPLwill undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions. |
| saline | Placebo comparator | Other: salinewill undergo intralesional saline. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age:Above 16 years old.
- Sex:Both males and female patients.
- Clinically and dermoscopically documented verruca.
- No verruca treatment in the last 2 weeks.
Key exclusion criteria (5 listed)
- History of photosensitivity disorder.
- Pregnant and lactating females.
- Diseases with risk of koebnerization e.g. Psoriasis and Lichen planus.
- Anogenital warts.
- Warts on head and neck.
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 |
|---|---|---|
| methylene blue / IPLtherapeutic | Other | methylene blue/IPL |
| IPLtherapeutic | Other | IPL |
| salineplacebo | Other | saline |
Primary outcome
disappearance of verruca
Time frame: 10 weeks
clinical and dermoscopic cure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Verruca Vulgaris
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
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RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Not yet recruitingPhase 2
Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris) (COVE-5)
Common Warts, Common Warts (Verruca Vulgaris)
Active, not recruitingPhase 2
Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts
Warts, Verruca (Warts)
RecruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-3)
Common Warts, Common Warts (Verruca Vulgaris)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylene blue / IPL, IPL and saline in people with Verruca Vulgaris, run by Alexandria University at 1 site in Egypt.
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 26 Jul 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disappearance of verruca (time frame: 10 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 Jul 2021.