Alopecia Areata Clinical Trial
Official title:
Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata: a Pilot Study of Patient Tolerability
Verified date | January 2024 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | June 6, 2023 |
Est. primary completion date | June 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | 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 areā¦ - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 12 weeks | |
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. | Baseline (pre-treatment), 12 weeks (post-treatment) | |
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. | 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. | Baseline (Pre-treatment), 12 weeks (Post-treatment) | |
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. | Baseline (Pre-treatment), 12 weeks (Post-treatment) | |
Secondary | Hair Regrowth of Treated Patch | Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss | 12 weeks | |
Secondary | 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 | |
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". | Baseline (pre-treatment), 12 weeks (post-treatment) |
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