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This is an interventional pilot study assessing the tolerability of needle-free delivery administration of ILTA with the Med-Jet as an alternative to conventional syringe and needle in patients with patchy pediatric alopecia areata. There will be a total of four (4) or five (5) visits necessary for study participation. The investigators hypothesize that the Med-Jet will have acceptable pain tolerability, efficacy, safety, and a positive impact on patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MedJet Device | Experimental | The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005" orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas (MedJet). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MedJet Device with intralesional triamcinolone | Combination Product | A standard sterile disposable 5 ml syringe will be used to draw TAC using standard sterile protocol. This syringe will be attached to the Med-Jet along with a sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection pressure used on the subject will start at 110 pounds per square inch (psi) and increased by 10 psi until a blanching wheal is observed. The optimal pressure will be recorded. The injections will be repeated multiple times at the optimal pressure until the targeted patch is completely treated. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey. | For the pain score assessment, patients will rate their pain from the needle-free injection using the Wong-Baker FACES Scale and a numerical rating scale, in which score ranges from 0-10 where 0 is no pain and 10 is the worst pain imaginable. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Reported Hair Loss | The patient-reported efficacy assessments will consist of the Patient-Reported Hair Loss and the 5-Point Patient-Reported. The Patient-Reported Hair Loss assessment includes 5 categories to assess how much of the patient's scalp is missing hair. Reported on a scale of 0-4, with 0 being no hair loss, and 4 nearly all or all hair loss. | Baseline (pre-treatment), 12 weeks (post-treatment) |
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Inclusion Criteria:
Diagnosed with alopecia areata by either:
Patient has at least 2 alopecic patches each measuring at least 2 cm2 and are…
Patient is a candidate for intralesional triamcinolone.
Patient able to give informed assent under IRB approval procedures when appropriate.
At least one parent or guardian is able to provide informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonal Shah, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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Recruited from UH derm providers who referred interested patients
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| ID | Title | Description |
|---|---|---|
| FG000 | MedJet Device | The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005" orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas (MedJet). MedJet Device with intralesional triamcinolone: A standard sterile disposable 5 ml syringe will be used to draw TAC using standard sterile protocol. This syringe will be attached to the Med-Jet along with a sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection pressure used on the subject will start at 110 pounds per square inch (psi) and increased by 10 psi until a blanching wheal is observed. The optimal pressure will be recorded. The injections will be repeated multiple times at the optimal pressure until the targeted patch is completely treated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MedJet Device | The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005" orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas (MedJet). MedJet Device with intralesional triamcinolone: A standard sterile disposable 5 ml syringe will be used to draw TAC using standard sterile protocol. This syringe will be attached to the Med-Jet along with a sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection pressure used on the subject will start at 110 pounds per square inch (psi) and increased by 10 psi until a blanching wheal is observed. The optimal pressure will be recorded. The injections will be repeated multiple times at the optimal pressure until the targeted patch is completely treated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey. | For the pain score assessment, patients will rate their pain from the needle-free injection using the Wong-Baker FACES Scale and a numerical rating scale, in which score ranges from 0-10 where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MedJet Device | The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005" orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas (MedJet). MedJet Device with intralesional triamcinolone: A standard sterile disposable 5 ml syringe will be used to draw TAC using standard sterile protocol. This syringe will be attached to the Med-Jet along with a sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection pressure used on the subject will start at 110 pounds per square inch (psi) and increased by 10 psi until a blanching wheal is observed. The optimal pressure will be recorded. The injections will be repeated multiple times at the optimal pressure until the targeted patch is completely treated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin atrophy | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sonal Shah, Director of Pediatric Dermatology | University Hospitals Cleveland Medical Center | 216-286-7285 | Sonal.Shah@UHhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Dec 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| Patient Reported Hair Regrowth | The 5-Point Patient-Reported Regrowth will ask the subject about their perceived amount of hair regrowth. Reported on a scale of 0-4, with 0 being no regrowth, and 4 being 100% regrowth. | 12 weeks |
| Change in Severity of Alopecia Tool (SALT) Score | SALT Score is a score of 0-100, where 0 is no hair loss, and 100 is complete hair loss. | Baseline (Pre-treatment), 12 weeks (Post-treatment) |
| Change in Alopecia Areata- Investigator Global Assessment (AA-IGA) | AA-IGA is measured on a score of 1-5, with 1 being mild hair loss, to 5 being severe hair loss. | Baseline (Pre-treatment), 12 weeks (Post-treatment) |
| Hair Regrowth of Treated Patch | Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss | 12 weeks |
| Hair Regrowth of Non-treated Patch | Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss | 12 weeks |
| Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment. | At each visit, subjects will answer either the Children's Dermatology Quality of Life Index (cCDLQI) (ages 6-11) or the Teenager's Quality of Life Index (T-QoL) (ages 12-17). Both the cCDLQI and T-QoL have the same scale ranges and directionality- 10 item questionnaire asking about skin troubles on a scale of 1-4, with 1 being "not at all" and 4 being "very much". | Baseline (pre-treatment), 12 weeks (post-treatment) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Change in Patient Reported Hair Loss | The patient-reported efficacy assessments will consist of the Patient-Reported Hair Loss and the 5-Point Patient-Reported. The Patient-Reported Hair Loss assessment includes 5 categories to assess how much of the patient's scalp is missing hair. Reported on a scale of 0-4, with 0 being no hair loss, and 4 nearly all or all hair loss. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment), 12 weeks (post-treatment) |
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|
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| Secondary | Patient Reported Hair Regrowth | The 5-Point Patient-Reported Regrowth will ask the subject about their perceived amount of hair regrowth. Reported on a scale of 0-4, with 0 being no regrowth, and 4 being 100% regrowth. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Change in Severity of Alopecia Tool (SALT) Score | SALT Score is a score of 0-100, where 0 is no hair loss, and 100 is complete hair loss. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-treatment), 12 weeks (Post-treatment) |
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| Secondary | Change in Alopecia Areata- Investigator Global Assessment (AA-IGA) | AA-IGA is measured on a score of 1-5, with 1 being mild hair loss, to 5 being severe hair loss. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-treatment), 12 weeks (Post-treatment) |
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| Secondary | Hair Regrowth of Treated Patch | Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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|
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| Secondary | Hair Regrowth of Non-treated Patch | Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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|
| Secondary | Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment. | At each visit, subjects will answer either the Children's Dermatology Quality of Life Index (cCDLQI) (ages 6-11) or the Teenager's Quality of Life Index (T-QoL) (ages 12-17). Both the cCDLQI and T-QoL have the same scale ranges and directionality- 10 item questionnaire asking about skin troubles on a scale of 1-4, with 1 being "not at all" and 4 being "very much". | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment), 12 weeks (post-treatment) |
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| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
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| D017437 |
| Skin and Connective Tissue Diseases |