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A pilot study of efficacy and safety of microneedling-assisted topical botulinum toxin A for the treatment of enlarged facial pores: a split-face randomized-controlled pilot study

Phase 4
Conditions
Enlarged facial pores
Botulinum toxin
Enlarged pores
Microneedle
Registration Number
TCTR20230418007
Lead Sponsor
Faculty of Medicine Siriraj Hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
nknown
Sex
All
Target Recruitment
25
Inclusion Criteria

1. Thai descendants
2. There are enlarged pores on both cheeks. By definition, enlarged pores must be visible to the naked eye (visible topographic enlarged facial pores) at a distance of 30 cm and examined by two dermatologists with a consensus.

Exclusion Criteria

1. Pregnant, breastfeeding, or after giving birth for no more than three months or plan to become pregnant during six months.
2. Using vitamin A compounds or chemical peeling agents or injecting botulinum toxin on the cheek area in the last six months
3. History of allergy to anesthetics or botulinum toxin
4. History of hypertrophic scars or keloids
5. Open wounds, infected skin, or skin rashes on the face
6. Having underlying diseases such as diabetes, collagen-related disorders, immunodeficiencies, or having an underlying condition that the researcher considers to be unsafe if participating in the program, such as epilepsy
7. History of regularly using steroids or smoking.
8. History of using anticoagulants, antiplatelet agents, or ginkgo leaf extract.
9. Volunteers with an implanted pacemaker with an implanted metallic device.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pore volume before treatment, 2 weeks, 1 month, 3 months, 6 months after treatment Antera 3D analysis
Secondary Outcome Measures
NameTimeMethod
Adverse events 1 week, 2 weeks, 1 month, 3 months, 6 months after treatment Clinical evaluation,Sebum production 2 weeks, 1 month, 3 months, 6 months after treatment Sebumeter
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