Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores
The Efficacy of Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores Compared to Intradermal Botulinum Toxin
1 other identifier
interventional
16
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2024
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2024
CompletedStudy Start
First participant enrolled
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2024
CompletedMarch 5, 2024
February 1, 2024
6 days
February 28, 2024
February 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score
the used pore scores, patients with visible pores took the score "1," and those with enlarged pores took "2." When black heads were embedded on facial pores the score was "3." The scores were assessed by 2 investigators who were blinded to the treatment used on each side.
Post-intervention, week 4 and week 16
Study Arms (2)
Microneedle patch with Botulinum toxin
EXPERIMENTALParticipants recieve microneedle path with 20 units Botulinum toxin at nose and cheek one side.
Intradermal Botulinum toxin injection
ACTIVE COMPARATORParticipants recieve intradermal 20 units Botulinum toxin injection at nose and cheek in other side.
Interventions
Eligibility Criteria
You may qualify if:
- At least 18 years old and concerned about enlarged pores
- Have pore size 0.3-0.6 mm
- Have pore parameter in each other side of faces not different more than 5%
You may not qualify if:
- Any neuromuscular condition
- Pregnancy or breast feeding
- History of allergy : Botulinum toxin, topical anesthesia
- History of keloid or hypertrophic scar
- History of coagulation or receiving medication that causes coagulation disorder
- Using drugs that have interaction with Botulinum toxin
- Using topical medication that improves enlarged pores in 1 month
- Taking medication that improves enlarged pores in 1 month
- Receiving the laser/treatment/chemical peeling in 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dhurakij Pundit University
Lak Si, Bangkok, Thailand
Related Publications (1)
Salem RM, Salah SAE, Ibrahim SE. Microbotox injection versus its topical application following microneedling in the treatment of wide facial pores: A split face comparative study. J Cosmet Dermatol. 2023 Apr;22(4):1249-1255. doi: 10.1111/jocd.15590. Epub 2023 Jan 6.
PMID: 36606384RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chotip Jitudomtham, MD
Dhurakij Pundit University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chotip Jitudomtham
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 5, 2024
Study Start
February 28, 2024
Primary Completion
March 5, 2024
Study Completion
June 25, 2024
Last Updated
March 5, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share