Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores

February 28, 2024 updated by: Chotip Jitudomtham, Dhurakij Pundit University

The Efficacy of Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores Compared to Intradermal Botulinum Toxin

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Lak Si, Bangkok, Thailand
        • Dhurakij Pundit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microneedle patch with Botulinum toxin
Participants recieve microneedle path with 20 units Botulinum toxin at nose and cheek one side.
Device: Microneedle patch
with 20 units botulinum toxin
Active Comparator: Intradermal Botulinum toxin injection
Participants recieve intradermal 20 units Botulinum toxin injection at nose and cheek in other side.
Device: Intradermal injection
with 20 units botulinum toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score
Time Frame: 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.
Post-intervention, week 4 and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dhurakij Pundit University

Investigators

  • Principal Investigator: Chotip Jitudomtham, MD, Dhurakij Pundit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Estimated)

March 5, 2024

Study Completion (Estimated)

June 25, 2024

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • COA022/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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