Trial Outcomes & Findings for Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca (NCT NCT05070754)
NCT ID: NCT05070754
Last Updated: 2024-04-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-04-05
Participant Flow
Unit of analysis: lesions
Participant milestones
| Measure |
Cold Atmospheric Plasma (CAP) Only
We conducted clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to dermatology, publications exist 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. The generated plasma stream is near skin temperature and exists on normal atmospheric pressure. In generation of plasma, there is no electric contact with the patient. Treatment does not increase skin surface temperature; the used helium gas is a noble gas and does not cause a chemical reaction with the skin. Flow of the gas is slow, thus there is no mechanical effect on skin.
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP): The treatment device in this study generates CAP. CAP has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator, which supplied 17 kHz, 6 µs width pulse at a power density of approximately 2 W/cm2 (AAPlasma, Philadelphia, PA) was connected to a 10 mm diameter quartz-covered copper electrode of 50 mm length and 1 mm quartz thickness with one end fused. 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 treated lesions for 2 minutes each, moving the electrode gently over the treatment area.
|
Cryotherapy Only
Current standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study have only one verruca lesion enrolled, and will receive SOC treatment for their identified condition.
Cryotherapy: 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.
|
CAP and Cryotherapy
Patients in this arm have more than one verruca lesion enrolled in the study. Thus, some of their lesions received CAP and some received SOC cryotherapy.
|
CAP and Cantharidin
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will have multiple lesions, with some receiving cantharidin SOC treatment for their identified condition and some receiving cold atmospheric plasma (CAP).
Canthardin Collodion: 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2 2
|
1 1
|
11 109
|
3 37
|
|
Overall Study
CAP
|
2 2
|
0 0
|
11 54
|
3 19
|
|
Overall Study
Cryotherapy
|
0 0
|
1 1
|
11 55
|
0 0
|
|
Overall Study
Cantharidin
|
0 0
|
0 0
|
0 0
|
3 18
|
|
Overall Study
COMPLETED
|
2 2
|
1 1
|
11 109
|
1 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
2 17
|
Reasons for withdrawal
| Measure |
Cold Atmospheric Plasma (CAP) Only
We conducted clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to dermatology, publications exist 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. The generated plasma stream is near skin temperature and exists on normal atmospheric pressure. In generation of plasma, there is no electric contact with the patient. Treatment does not increase skin surface temperature; the used helium gas is a noble gas and does not cause a chemical reaction with the skin. Flow of the gas is slow, thus there is no mechanical effect on skin.
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP): The treatment device in this study generates CAP. CAP has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator, which supplied 17 kHz, 6 µs width pulse at a power density of approximately 2 W/cm2 (AAPlasma, Philadelphia, PA) was connected to a 10 mm diameter quartz-covered copper electrode of 50 mm length and 1 mm quartz thickness with one end fused. 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 treated lesions for 2 minutes each, moving the electrode gently over the treatment area.
|
Cryotherapy Only
Current standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study have only one verruca lesion enrolled, and will receive SOC treatment for their identified condition.
Cryotherapy: 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.
|
CAP and Cryotherapy
Patients in this arm have more than one verruca lesion enrolled in the study. Thus, some of their lesions received CAP and some received SOC cryotherapy.
|
CAP and Cantharidin
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will have multiple lesions, with some receiving cantharidin SOC treatment for their identified condition and some receiving cold atmospheric plasma (CAP).
Canthardin Collodion: 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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Cold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
Baseline characteristics by cohort
| Measure |
Cold Atmospheric Plasma (CAP) Only
n=2 Lesions
We conducted clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to dermatology, publications exist 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. The generated plasma stream is near skin temperature and exists on normal atmospheric pressure. In generation of plasma, there is no electric contact with the patient. Treatment does not increase skin surface temperature; the used helium gas is a noble gas and does not cause a chemical reaction with the skin. Flow of the gas is slow, thus there is no mechanical effect on skin.
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP): The treatment device in this study generates CAP. CAP has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator, which supplied 17 kHz, 6 µs width pulse at a power density of approximately 2 W/cm2 (AAPlasma, Philadelphia, PA) was connected to a 10 mm diameter quartz-covered copper electrode of 50 mm length and 1 mm quartz thickness with one end fused. 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 treated lesions for 2 minutes each, moving the electrode gently over the treatment area.
|
Cryotherapy Only
n=1 Lesions
Current standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study have only one verruca lesion enrolled, and will receive SOC treatment for their identified condition.
Cryotherapy: 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.
|
CAP and Cryotherapy
n=109 Lesions
Patients in this arm have more than one verruca lesion enrolled in the study. Thus, some of their lesions received CAP and some received SOC cryotherapy.
|
CAP and Cantharidin
n=37 Lesions
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will have multiple lesions, with some receiving cantharidin SOC treatment for their identified condition and some receiving cold atmospheric plasma (CAP).
Canthardin Collodion: 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.
|
Total
n=149 Lesions
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
6.5 years
n=5 Participants
|
10 years
n=7 Participants
|
10 years
n=5 Participants
|
7 years
n=4 Participants
|
9.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
11 participants
n=5 Participants
|
3 participants
n=4 Participants
|
17 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Lesions Treated With Cold Atmospheric Plasma (CAP)
n=75 lesions
This arm represents lesions that were randomized to receive treatment with cold atmospheric plasma (CAP) therapy.
|
Lesions Treated With Standard of Care (SOC)
n=74 lesions
This arm represents lesions that were randomized to receive SOC therapy (cryotherapy or cantharidin, depending on the lesion).
|
|---|---|---|
|
Numbers of Lesions With no Response
|
8 lesions
|
9 lesions
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Lesions Treated With Cold Atmospheric Plasma (CAP)
n=75 lesions
This arm represents lesions that were randomized to receive treatment with cold atmospheric plasma (CAP) therapy.
|
Lesions Treated With Standard of Care (SOC)
n=74 lesions
This arm represents lesions that were randomized to receive SOC therapy (cryotherapy or cantharidin, depending on the lesion).
|
|---|---|---|
|
Numbers of Lesions With Partial Response
|
23 lesions
|
15 lesions
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
Targeted lesion is no longer grossly visible.
Outcome measures
| Measure |
Lesions Treated With Cold Atmospheric Plasma (CAP)
n=75 lesions
This arm represents lesions that were randomized to receive treatment with cold atmospheric plasma (CAP) therapy.
|
Lesions Treated With Standard of Care (SOC)
n=74 lesions
This arm represents lesions that were randomized to receive SOC therapy (cryotherapy or cantharidin, depending on the lesion).
|
|---|---|---|
|
Numbers of Lesions With Complete Response
|
40 lesions
|
45 lesions
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Lesions Treated With Cold Atmospheric Plasma (CAP)
n=75 lesions
This arm represents lesions that were randomized to receive treatment with cold atmospheric plasma (CAP) therapy.
|
Lesions Treated With Standard of Care (SOC)
n=74 lesions
This arm represents lesions that were randomized to receive SOC therapy (cryotherapy or cantharidin, depending on the lesion).
|
|---|---|---|
|
Post-Treatment CAP Tolerability Questionnaire
|
10 lesions
|
42 lesions
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Lesions Treated With Cold Atmospheric Plasma (CAP)
n=75 lesions
This arm represents lesions that were randomized to receive treatment with cold atmospheric plasma (CAP) therapy.
|
Lesions Treated With Standard of Care (SOC)
n=74 lesions
This arm represents lesions that were randomized to receive SOC therapy (cryotherapy or cantharidin, depending on the lesion).
|
|---|---|---|
|
Score of Visual Analogue Scale Associated With Treatment
|
2.5 units from 0-10 on VAS scale
Interval 0.0 to 10.0
|
0.9 units from 0-10 on VAS scale
Interval 0.0 to 8.0
|
Adverse Events
Cold Atmospheric Plasma (CAP) Only
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cryotherapy Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CAP and Cryotherapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
CAP and Cantharidin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cold Atmospheric Plasma (CAP) Only
n=2 participants at risk
We conducted clinical trial of a floating electrode-dielectric barrier device (FE-DBD), a Cold Atmospheric Plasma (CAP) device for treatment of Verrucae Vulgaris and Molluscum Contagiosum. While novel to dermatology, publications exist 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. The generated plasma stream is near skin temperature and exists on normal atmospheric pressure. In generation of plasma, there is no electric contact with the patient. Treatment does not increase skin surface temperature; the used helium gas is a noble gas and does not cause a chemical reaction with the skin. Flow of the gas is slow, thus there is no mechanical effect on skin.
Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP): The treatment device in this study generates CAP. CAP has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator, which supplied 17 kHz, 6 µs width pulse at a power density of approximately 2 W/cm2 (AAPlasma, Philadelphia, PA) was connected to a 10 mm diameter quartz-covered copper electrode of 50 mm length and 1 mm quartz thickness with one end fused. 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 treated lesions for 2 minutes each, moving the electrode gently over the treatment area.
|
Cryotherapy Only
n=1 participants at risk
Current standard of care (SOC) for treating Verruca Vulgaris in Children is cryotherapy. Patients randomized to this arm of the study have only one verruca lesion enrolled, and will receive SOC treatment for their identified condition.
Cryotherapy: 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.
|
CAP and Cryotherapy
n=11 participants at risk
Patients in this arm have more than one verruca lesion enrolled in the study. Thus, some of their lesions received CAP and some received SOC cryotherapy.
|
CAP and Cantharidin
n=3 participants at risk
SOC for treatment of Molluscum Contagiosum is cantharidin. Patients randomized to this arm of the study will have multiple lesions, with some receiving cantharidin SOC treatment for their identified condition and some receiving cold atmospheric plasma (CAP).
Canthardin Collodion: 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.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Patient-reported AE: Pain
|
50.0%
1/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
27.3%
3/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
|
Skin and subcutaneous tissue disorders
Patient-reported AE: Redness
|
0.00%
0/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
9.1%
1/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
100.0%
3/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
|
Skin and subcutaneous tissue disorders
Patient-Reported AE: Other Color Change
|
0.00%
0/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
9.1%
1/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
|
Skin and subcutaneous tissue disorders
Patient-Reported AE: Blistering
|
0.00%
0/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
18.2%
2/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
33.3%
1/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
|
Skin and subcutaneous tissue disorders
Patient-Reported AE: Scabbing
|
0.00%
0/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
33.3%
1/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
|
Skin and subcutaneous tissue disorders
Physician-determined Sequela: Hyperpigmentation
|
50.0%
1/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
100.0%
1/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
72.7%
8/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
100.0%
3/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
|
Skin and subcutaneous tissue disorders
Physician-determined Sequela: Hypopigmentation
|
0.00%
0/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
100.0%
1/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
54.5%
6/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
66.7%
2/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
|
Skin and subcutaneous tissue disorders
Physician-determined Sequela: Erythema
|
0.00%
0/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
18.2%
2/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
|
Skin and subcutaneous tissue disorders
Physician-determined Sequela: Scarring
|
0.00%
0/2 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/1 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
18.2%
2/11 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
0.00%
0/3 • 4 months (maximum of 3 months of treatment, then 1 month post-treatment)
Adverse events were categorized as patient-reported events or physician-determined sequelae post-treatment.
|
Additional Information
Dr. Lara Wine Lee
Medical University of South Carolina
Phone: (843) 792-3021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place