Adults 6 to 17, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey.Primary· 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.
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.
Pre-treatment
Group
Value
95% CI
MedJet Device
1.5
± 0.5
Post-treatment
Group
Value
95% CI
MedJet Device
1
± 0
Patient Reported Hair RegrowthSecondary· 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.
Group
Value
95% CI
MedJet Device
2.5
± 0.5
Change in Severity of Alopecia Tool (SALT) ScoreSecondary· 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.
Pre-treatment
Group
Value
95% CI
MedJet Device
28.8
± 23.7
Post-treatment
Group
Value
95% CI
MedJet Device
11.2
± 11.2
Change in Alopecia Areata- Investigator Global Assessment (AA-IGA)Secondary· 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.
Pre-treatment
Group
Value
95% CI
MedJet Device
3
± 1
Post-treatment
Group
Value
95% CI
MedJet Device
2
± 1
Hair Regrowth of Treated PatchSecondary· 12 weeks
Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss
Group
Value
95% CI
MedJet Device
4.5
± 0.5
Hair Regrowth of Non-treated PatchSecondary· 12 weeks
Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss
Group
Value
95% CI
MedJet Device
4.5
± 0.5
Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment.Secondary· 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".
Pre-treatment
Group
Value
95% CI
MedJet Device
4
± 3
Post-treatment
Group
Value
95% CI
MedJet Device
2
± 3.1
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospitals Cleveland Medical Center
Last refreshed: 31 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05278858.