Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores

Phase 3

Active, not recruiting

• Conditions: Enlarged Pores
• Interventions: Device: Intradermal injection; Device: Microneedle patch

• Registration Number: NCT06293755
• Lead Sponsor: Dhurakij Pundit University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-28
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Primary Completion: 2024-03-05
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Study Completion: 2024-06-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intradermal Botulinum toxin injection	Intradermal injection	Participants recieve intradermal 20 units Botulinum toxin injection at nose and cheek in other side.
Microneedle patch with Botulinum toxin	Microneedle patch	Participants recieve microneedle path with 20 units Botulinum toxin at nose and cheek one side.

Primary Outcome Measures

Name	Time	Method
Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score	Post-intervention, week 4 and week 16	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.

Trial Locations

Locations (1)

Dhurakij Pundit University; 🇹🇭 Lak Si, Bangkok, Thailand