Verruca VulgarisPhase 4NCT05070754

Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca

A Phase 4 study testing Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP), Cryotherapy and Canthardin Collodion in people with Verruca Vulgaris and Molluscum Contagiosum Skin Infection, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 21 years
Conditions the study is for: Verruca Vulgaris, Molluscum Contagiosum Skin Infection
What is being tested?: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP), Cryotherapy and Canthardin Collodion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2021to 31 Dec 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

All patients from 4-21 years old with at least 1 lesion of either verruca vulgaris or molluscum contagiosum
Willingness of the participant and their guardian to provide consent when applicable

Who cannot join

Unwillingness to participate in the study
Received any treatment on the lesion in the past month, as determined by review of participant medical record
Immunodeficiency as determined by review of participant medical record
Adverse response to prior treatments as determined by review of medical record
Signs of self-resolution as determined by study team members
Conditions that lead to excessive scarring as determined by study team members
Facial and genital lesions as determined by study team members

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients

This study is going to test a cold atmospheric plasma device (CAP), in particular a floating electrode-dielectric barrier device (FE-DBD), to treat warts and molluscum. The treatment device in this study generates cold atmospheric plasma (gaseous ionized molecules) to rid the virus from the body. Based on the successes of previous dermatologic studies, FE-DBD is being tested for this study to treat warts and molluscum. Patients will be enrolled to test the efficacy and safety of this device. The duration of the study is 4-12 weeks depending on treatment clearance. The number of lesions will be chosen by the dermatologist. Patients will receive standard of care therapy and/or NTAP depending on the number of lesions.

Conditions: Verruca Vulgaris, Molluscum Contagiosum Skin Infection
Being tested: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP), Cryotherapy, Canthardin Collodion
Keywords: Plasma, Cryotherapy, Pediatrics, Warts, Molluscum, Dermatology, Cantharidin
Medical subject headings: Warts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)Device
Also called Non-thermal atmospheric pressure plasma (NTAP)
The treatment device in this study generates cold atmospheric plasma. Cold atmospheric plasma has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator supplying 20 kilovolt pulse of 20-ns pulse width at 200 Hz (FPG10-01NM10, FID GmbH, Burbach, Germany) to a 5-mm diameter quartz-covered copper electrode of 10-cm length and 1 - 13mm quartz thickness. These nanosecond pulse parameters were chosen to provide sufficient treatment dose at the high level of plasma uniformity required to avoid any tissue damage. We will treat the lesions for approximately 1 to 2 minutes each, moving the electrode gently over the treatment area.
CryotherapyDevice
Also called Cold Therapy, Liquid Nitrogen
Cryotherapy refers to the application of liquid nitrogen using a cryospray device in order to freeze a lesion of interest. Treatment is repeated every few weeks until the lesion of interest has disappeared. It is considered SOC for the treatment of warts.
Canthardin CollodionDrug
Also called Cantharidin
Chemical compound that acts as a vesicant to form a blister around treatment area. The blister lifts the lesion of interest away from the skin, causing it to slough off in a few days. It is used as SOC for the treatment of Molluscum Contagiosum.

Study groups in NCT05070754
Study group	Role	What they receive
Cold Atmospheric Plasma (CAP)	Experimental	We are proposing a clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for the treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to the medical field, and especially to dermatology, there are already a number of publications regarding its use on human skin in adults and children. CAP devices utilize noble gases (such as helium) to deliver plasma state matter to the skin. As its name implies, the generated plasma stream is of near skin temperature and it exists on normal atmospheric pressure. During the generation of the plasma there is no electric contact with the patient. The treatment does not increase skin surface temperature and the used helium gas, the same as used for balloons, being a noble gas does not cause a chemical reaction with the skin. The flow of the gas is slow, thus there is no mechanical effect on the skin. Receives: Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)
Cryotherapy	Active comparator	Current standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study will receive SOC treatment for their identified condition. Receives: Device: Cryotherapy
Cantharidin	Active comparator	SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition. Receives: Drug: Canthardin Collodion

What is being measured

The primary outcome is the main question the study is designed to answer.

Numbers of Lesions With no Response
Absence of change in appearance of targeted lesion. Molluscum is defined as the visualization of a central umbilication with polylobular, white to yellow, amorphous structures. A peripheral crown of radiating or punctiform vessels may also be present. Warts are defined as grouped papillae, with dotted or loop vessels, and/or hemorrhagic points and lines often surrounded by a whitish halo.
Measured: 12 weeks
Numbers of Lesions With Partial Response
There is change in the size, dyspigmentation, or discomfort of the targeted lesion as compared to its appearance and symptoms at the initial visit, but the lesion remains grossly visible. Molluscum is defined as the visualization of a central umbilication with polylobular, white to yellow, amorphous structures. A peripheral crown of radiating or punctiform vessels may also be present. Warts are defined as grouped papillae, with dotted or loop vessels, and/or hemorrhagic points and lines often surrounded by a whitish halo. Changes in the characteristics of the targeted lesions will be evaluated by a dermatologist and documented via photographs at follow-up visits at 4, 8, and 12 weeks, with the final outcome measured at the 12-week visit.
Measured: 12 weeks
Numbers of Lesions With Complete Response
Targeted lesion is no longer grossly visible.
Measured: 12 weeks

Secondary outcomes (2)

Post-Treatment CAP Tolerability Questionnaire
This questionnaire measures tolerability of cold atmospheric plasma treatment. Assessment of dryness, peeling, scaling, erythema, edema, stinging, burning sensation, itching, scarring and dyspigmentation will each be assessed individually. Participants were asked about these symptoms at a 1-week post-first treatment phone call, and then at every in-person follow up visit. Outcome data represents the number of total lesions in each treatment group in which a participant reported at least one of the above adverse symptoms. Results of specific AEs are detailed in the Adverse Event section.
Measured: 12 weeks
Score of Visual Analogue Scale Associated With Treatment
The visual analogue scale (VAS) is a validated subjective measurement of pain experienced by the patient. It consists of visual-numeric scale, numbered from 0-10. (0) indicate absence of pain or "no pain at all", while (10) indicates severe pain or "worst imaginable pain". This is supplemented by six faces with different expressions, ranging from happy to extremely upset. Each facial expression is assigned a numerical scale from 0 to 10.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202131 Dec 2022

First posted7 Oct 2021
Study start2 Dec 2021
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Verruca VulgarisStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: During a clinical care visit, if a patient is eligible and agrees to participate, lesions will be selected by the dermatologist prior to procedure.The lesions will be marked randomly for a certain treatment regimen. The number of lesions treated will not exceed standard of care (SOC) recommendations. They will be determined by provider assessment and anatomical location. Participants with one lesion will receive either non-thermal atmospheric plasma (NTAP) or SOC. SOC is cryotherapy for warts and cantharidin for molluscum. Participants with greater than 2 lesions will receive equal treatment of NTAP and SOC. The number of lesions treated will be based off the providers assessment and anatomical location. Treatment of a single lesion or an odd number of multiple lesions will be based off a randomized list. All SOC lesions will be treated first to reduce the number of patients not wanting return to the more painful modality.
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070754
Sponsor's protocol ID: 106689
Status last verified: Mar 2024
First submitted: 27 Sep 2021
Last updated: 5 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Walker CL, Shope CN, Andrews LA, Atherton KM, Beck T, Santa Lucia G, Fridman G, Friedman PC, Cotton CH, Wine Lee L. A randomized controlled trial analyzing nonthermal atmospheric plasma for the treatment of verruca vulgaris in pediatric patients. J Am Acad Dermatol. 2025 Jan;92(1):46-50. doi: 10.1016/j.jaad.2024.07.1522. Epub 2024 Aug 27.
PubMed 39197495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
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)

All Verruca Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients
ClinicalTrials.gov ID: NCT05070754
Acronym / sponsor ID: 106689
Conditions: Verruca Vulgaris, Molluscum Contagiosum Skin Infection
Keywords: Plasma, Cryotherapy, Pediatrics, Warts, Molluscum, Dermatology, Cantharidin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: The Skin Center Dermatology Group
Study start: 2 Dec 2021 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 7 Oct 2021 (actual)
Results: Posted 5 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: During a clinical care visit, if a patient is eligible and agrees to participate, lesions will be selected by the dermatologist prior to procedure.The lesions will be marked randomly for a certain treatment regimen. The number of lesions treated will not exceed standard of care (SOC) recommendations. They will be determined by provider assessment and anatomical location. Participants with one lesion will receive either non-thermal atmospheric plasma (NTAP) or SOC. SOC is cryotherapy for warts and cantharidin for molluscum. Participants with greater than 2 lesions will receive equal treatment of NTAP and SOC. The number of lesions treated will be based off the providers assessment and anatomical location. Treatment of a single lesion or an odd number of multiple lesions will be based off a randomized list. All SOC lesions will be treated first to reduce the number of patients not wanting return to the more painful modality.

Arm	Type	Receives
Cold Atmospheric Plasma (CAP)	Experimental	Device: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)We are proposing a clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for the treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to the medical field, and especially to dermatology, there are already a number of publications regarding its use on human skin in adults and children. CAP devices utilize noble gases (such as helium) to deliver plasma state matter to the skin. As its name implies, the generated plasma stream is of near skin temperature and it exists on normal atmospheric pressure. During the generation of the plasma there is no electric contact with the patient. The treatment does not increase skin surface temperature and the used helium gas, the same as used for balloons, being a noble gas does not cause a chemical reaction with the skin. The flow of the gas is slow, thus there is no mechanical effect on the skin.
Cryotherapy	Active comparator	Device: CryotherapyCurrent standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.
Cantharidin	Active comparator	Drug: Canthardin CollodionSOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will receive SOC treatment for their identified condition.

Who may qualify

Ages: 4 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

All patients from 4-21 years old with at least 1 lesion of either verruca vulgaris or molluscum contagiosum
Willingness of the participant and their guardian to provide consent when applicable

Key exclusion criteria (7 listed)

Unwillingness to participate in the study
Received any treatment on the lesion in the past month, as determined by review of participant medical record
Immunodeficiency as determined by review of participant medical record
Adverse response to prior treatments as determined by review of medical record
Signs of self-resolution as determined by study team members

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
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)Also: Non-thermal atmospheric pressure plasma (NTAP)The treatment device in this study generates cold atmospheric plasma. Cold atmospheric plasma has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator supplying 20 kilovolt pulse of 20-ns pulse width at 200 Hz (FPG10-01NM10, FID GmbH, Burbach, Germany) to a 5-mm diameter quartz-covered copper electrode of 10-cm length and 1 - 13mm quartz thickness. These nanosecond pulse parameters were chosen to provide sufficient treatment dose at the high level of plasma uniformity required to avoid any tissue damage. We will treat the lesions for approximately 1 to 2 minutes each, moving the electrode gently over the treatment area.	Device	Cold Atmospheric Plasma (CAP)
CryotherapyAlso: Cold Therapy, Liquid NitrogenCryotherapy refers to the application of liquid nitrogen using a cryospray device in order to freeze a lesion of interest. Treatment is repeated every few weeks until the lesion of interest has disappeared. It is considered SOC for the treatment of warts.	Device	Cryotherapy
Canthardin CollodionAlso: CantharidinChemical compound that acts as a vesicant to form a blister around treatment area. The blister lifts the lesion of interest away from the skin, causing it to slough off in a few days. It is used as SOC for the treatment of Molluscum Contagiosum.	Drug	Cantharidin

Primary outcome

Numbers of Lesions With no Response
Time frame: 12 weeks
Absence of change in appearance of targeted lesion. Molluscum is defined as the visualization of a central umbilication with polylobular, white to yellow, amorphous structures. A peripheral crown of radiating or punctiform vessels may also be present. Warts are defined as grouped papillae, with dotted or loop vessels, and/or hemorrhagic points and lines often surrounded by a whitish halo.
Numbers of Lesions With Partial Response
Time frame: 12 weeks
There is change in the size, dyspigmentation, or discomfort of the targeted lesion as compared to its appearance and symptoms at the initial visit, but the lesion remains grossly visible. Molluscum is defined as the visualization of a central umbilication with polylobular, white to yellow, amorphous structures. A peripheral crown of radiating or punctiform vessels may also be present. Warts are defined as grouped papillae, with dotted or loop vessels, and/or hemorrhagic points and lines often surrounded by a whitish halo. Changes in the characteristics of the targeted lesions will be evaluated by a dermatologist and documented via photographs at follow-up visits at 4, 8, and 12 weeks, with the final outcome measured at the 12-week visit.
Numbers of Lesions With Complete Response
Time frame: 12 weeks
Targeted lesion is no longer grossly visible.

2 secondary outcomes

Post-Treatment CAP Tolerability Questionnaire
Time frame: 12 weeks
Score of Visual Analogue Scale Associated With Treatment
Time frame: 12 weeks

Results and safety

Results posted to the registry on 5 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cold Atmospheric Plasma (CAP) Only	2	2
Cryotherapy Only	1	1
CAP and Cryotherapy	11	11
CAP and Cantharidin	3	1

Primary outcome: Numbers of Lesions With no Response

Time frame: 12 weeks. Number. Unit: lesions

Measure	Lesions Treated With Cold Atmospheric Plasma (CAP) n = 16	Lesions Treated With Standard of Care (SOC) n = 15
Value	8	9

Lesions Treated With Standard of Care (SOC): p = 0.534, Chi-squared

Population analysed: The analyzed unit for this outcome is individual lesions. The sum of the number of participants in the two categories being higher than the total number of participants enrolled in the study is a result of the two categories not being mutually exclusive, as participants could have multiple lesions enrolled that were randomized to either CAP or SOC.

Primary outcome: Numbers of Lesions With Partial Response

Time frame: 12 weeks. Number. Unit: lesions

Measure	Lesions Treated With Cold Atmospheric Plasma (CAP) n = 16	Lesions Treated With Standard of Care (SOC) n = 15
Value	23	15

Lesions Treated With Standard of Care (SOC): p = 0.534, Chi-squared

Primary outcome: Numbers of Lesions With Complete Response

Time frame: 12 weeks. Number. Unit: lesions

Measure	Lesions Treated With Cold Atmospheric Plasma (CAP) n = 16	Lesions Treated With Standard of Care (SOC) n = 15
Value	40	45

Lesions Treated With Standard of Care (SOC): p = 0.534, Chi-squared

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months (maximum of 3 months of treatment, then 1 month post-treatment). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cold Atmospheric Plasma (CAP) Only	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cryotherapy Only	0 of 1 (0%)	1 of 1 (100%)	0 of 1
CAP and Cryotherapy	0 of 11 (0%)	9 of 11 (81.8%)	0 of 11
CAP and Cantharidin	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Limitations and caveats (from the sponsor): Limitations: * Study was adequately powered with the number of lesions, but a small number of patients enrolled * Low enrollment of patients with skin of color * Patients limited to only three treatments with the NTAP device * Assessment of sustained treatment response was limited to 4 weeks after treatment \& may not represent long-term response * Post-treatment sequelae were measured at the end of the study period. We are unable to determine whether they persisted or self-resolved.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39197495Walker CL, Shope CN, Andrews LA, Atherton KM, Beck T, Santa Lucia G, Fridman G, Friedman PC, Cotton CH, Wine Lee L. A randomized controlled trial analyzing nonthermal atmospheric plasma for the treatment of verruca vulgaris in pediatric patients. J Am Acad Dermatol. 2025 Jan;92(1):46-50. doi: 10.1016/j.jaad.2024.07.1522. Epub 2024 Aug 27.
Individual participant dataSharing planned: No

Related trials for Verruca Vulgaris

Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
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.

Lara Wine Lee, MD, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 7 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 5 Apr 2024. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Numbers of Lesions With no Response (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT05070754, which also lists 1 linked publication.

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 5 Apr 2024.