The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis
ConditionAtopic Dermatitis (AD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaniel Kaplan
About this trial
The purpose of this study is to understand cellular and molecular interactions in the skin of participants with mild-to-moderate AD, and how botulinum toxin alters these interactions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years or older at time of consent
BSA ≤ 10%
IGA ≤ 3
No past biologic therapy
Disqualifiers
Age less than 18 years old
Pregnant or breastfeeding
Has medical comorbidity such as end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure
Has had prior exposure to biologic treatments or has had prior treatment with systemic non-biologics (e.g. methotrexate) within 12 weeks
Trial design
Design model
Sequential
Treatments tested in this trial
Onabotulinum Toxin Type A - Phase 1b
DrugThe lesions receiving Botulinum toxin will get five 0.1 mL intradermal injections of 5 units of Botulinum toxin which equates to 25 units per lesion and 50 units per patient.
Onabotulinum Toxin Type A - Phase 2
DrugThe lesions receiving Botulinum toxin will get five 0.1 mL intradermal injections of 5 units of Botulinum toxin which equates to 25 units per lesion and 75 units per patient.
Treatment groups
8 Participants
are divided into 2 treatment groupsGroup A: Onabotulinum Toxin Type A - Phase 1bExperimental treatment 1 intervention
Group B: Onabotulinum Toxin Type A - Phase 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage change in EASI scores at Day 28 as compared to baseline.
Eczema Area and Severity Index (EASI) total score from 0-72, with higher score indicating more severity. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72.
Time frame
At Day 282
Percentage change in PGA at Day 28 as compared to baseline.
The Physician's Global Assessment (PGA) is a clinician-reported measure used to assess the overall severity of atopic dermatitis (AD) at a single time point. It utilizes a scale of 5-points; total scale ranging from 0 (clear) to 5 (severe disease). The PGA score represents overall disease severity based on clinical signs including erythema, induration/papulation, lichenification, and oozing/crusting. Higher scores indicate greater disease severity.
Time frame
At Day 28Secondary outcomes
1
Percentage change in transcriptional mRNA in immune and non-immune cells in skin biopsies, up to Day 28, as compared to baseline.
Skin biopsies used to analyze transcriptional mRNA in immune and non-immune cells. Expression levels tested by Xenium Spatial Cell Imaging; a high-resolution, spatial transcriptomics platform used to perform single-cell resolution analysis of cell populations by mapping their gene expression profiles.
Time frame
Until last biopsy, up to Day 282
Percentage change in spatial distribution of specific cell types in skin biopsies, up to Day 28, as compared to baseline.
Skin biopsies used to analyze spatial location of immune and non-immune cells. Expression levels tested by Xenium Spatial Cell Imaging; a high-resolution, spatial transcriptomics platform used to perform single-cell resolution analysis of cell populations by mapping their spatial distribution profiles.
Time frame
Until last biopsy, up until Day 28Sponsors and contacts
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Source ClinicalTrials.gov