Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores

NCT ID: NCT06293755

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2024-06-25

Brief Summary

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

Detailed Description

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Conditions

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Enlarged Pores

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Microneedle patch with Botulinum toxin

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

Group Type EXPERIMENTAL

Microneedle patch

Intervention Type DEVICE

with 20 units botulinum toxin

Intradermal Botulinum toxin injection

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

Group Type ACTIVE_COMPARATOR

Intradermal injection

Intervention Type DEVICE

with 20 units botulinum toxin

Interventions

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Microneedle patch

with 20 units botulinum toxin

Intervention Type DEVICE

Intradermal injection

with 20 units botulinum toxin

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dhurakij Pundit University

OTHER

Sponsor Role lead

Responsible Party

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Chotip Jitudomtham

Chotip Jitudomtham

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chotip Jitudomtham, MD

Role: PRINCIPAL_INVESTIGATOR

Dhurakij Pundit University

Locations

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Dhurakij Pundit University

Lak Si, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 36606384 (View on PubMed)

Other Identifiers

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COA022/66

Identifier Type: -

Identifier Source: org_study_id

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