Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores

Dhurakij Pundit University

Status and phase: Active, not recruiting; Phase 3

Conditions: Enlarged Pores

Treatments: Device: Intradermal injection; Device: Microneedle patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06293755

COA022/66

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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%

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Microneedle patch with Botulinum toxin

Experimental group

Description:

Participants recieve microneedle path with 20 units Botulinum toxin at nose and cheek one side.

Treatment:

Device: Microneedle patch

Intradermal Botulinum toxin injection

Active Comparator group

Description:

Participants recieve intradermal 20 units Botulinum toxin injection at nose and cheek in other side.

Treatment:

Device: Intradermal injection