Alopecia Areata
Conditions
Keywords
Pediatric
Brief summary
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.
Interventions
COMBINATION_PRODUCTMedJet 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.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with alopecia areata by either: * A board-certified dermatologist, OR * Dermatology Nurse Practitioner, OR * Skin punch biopsy * Patient has at least 2 alopecic patches each measuring at least 2 cm2 and are… * Located on contralateral body sites OR * Within the same body site but separated by ≥ 1 cm * 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
* Patient has alopecia totalis, alopecia universalis, or alopecia areata with ophiasis pattern. * Known allergy or hypersensitivity to triamcinolone acetonide * Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study. * Patient is unable/unwilling to provide informed assent when applicable. * Known medical diagnosis or use of a medication that alters pain response at time of injection. * Active infection at site designated for injection. * If currently being treated for alopecia areata, the current treatment regimen has been started within less than 4 weeks of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey. | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Hair Regrowth | 12 weeks | 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. |
| Change in Severity of Alopecia Tool (SALT) Score | Baseline (Pre-treatment), 12 weeks (Post-treatment) | SALT Score is a score of 0-100, where 0 is no hair loss, and 100 is complete hair loss. |
| Change in Alopecia Areata- Investigator Global Assessment (AA-IGA) | Baseline (Pre-treatment), 12 weeks (Post-treatment) | AA-IGA is measured on a score of 1-5, with 1 being mild hair loss, to 5 being severe hair loss. |
| Change in Patient Reported Hair Loss | Baseline (pre-treatment), 12 weeks (post-treatment) | 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. |
| Hair Regrowth of Non-treated Patch | 12 weeks | Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss |
| Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment. | Baseline (pre-treatment), 12 weeks (post-treatment) | 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. |
| Hair Regrowth of Treated Patch | 12 weeks | Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss |
Countries
United States
Participant flow
Recruitment details
Recruited from UH derm providers who referred interested patients
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | MedJet Device |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MedJet Device | Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey. | 3.7 score on a scale | Standard Deviation 2.9 |
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.
Time frame: Baseline (Pre-treatment), 12 weeks (Post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MedJet Device | Change in Alopecia Areata- Investigator Global Assessment (AA-IGA) | Pre-treatment | 3 score on a scale | Standard Deviation 1 |
| MedJet Device | Change in Alopecia Areata- Investigator Global Assessment (AA-IGA) | Post-treatment | 2 score on a scale | Standard Deviation 1 |
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.
Time frame: Baseline (pre-treatment), 12 weeks (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MedJet Device | Change in Patient Reported Hair Loss | Pre-treatment | 1.5 score on a scale | Standard Deviation 0.5 |
| MedJet Device | Change in Patient Reported Hair Loss | Post-treatment | 1 score on a scale | Standard Deviation 0 |
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.
Time frame: Baseline (Pre-treatment), 12 weeks (Post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MedJet Device | Change in Severity of Alopecia Tool (SALT) Score | Pre-treatment | 28.8 score on a scale | Standard Deviation 23.7 |
| MedJet Device | Change in Severity of Alopecia Tool (SALT) Score | Post-treatment | 11.2 score on a scale | Standard Deviation 11.2 |
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.
Time frame: Baseline (pre-treatment), 12 weeks (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MedJet Device | Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment. | Pre-treatment | 4 score on a scale | Standard Deviation 3 |
| MedJet Device | Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment. | Post-treatment | 2 score on a scale | Standard Deviation 3.1 |
Secondary
Hair Regrowth of Non-treated Patch
Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MedJet Device | Hair Regrowth of Non-treated Patch | 4.5 score on a scale | Standard Deviation 0.5 |
Secondary
Hair Regrowth of Treated Patch
Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MedJet Device | Hair Regrowth of Treated Patch | 4.5 score on a scale | Standard Deviation 0.5 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MedJet Device | Patient Reported Hair Regrowth | 2.5 score on a scale | Standard Deviation 0.5 |