Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores

Enlarged Pores Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06293755
• Other study ID #: COA022/66
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 28, 2024
• Est. completion date: June 25, 2024

Study information

• Verified date: February 2024
• Source: Dhurakij Pundit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: June 25, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enlarged Pores

Intervention

Device:
• Microneedle patch
with 20 units botulinum toxin
• Intradermal injection
with 20 units botulinum toxin

Locations

Country	Name	City	State
Thailand	Dhurakij Pundit University	Lak Si	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Dhurakij Pundit University

Country where clinical trial is conducted

Thailand, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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