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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220527006
Enrollment
30
Registered
2022-05-27
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

visible topographic enlarged facial pores enlarged facial pores

Interventions

Botulinum toxin A, 16 units in 1 ml of normal saline, was applied to the randomized treatment side of the participant&#039
s face, then the micro-needling was used. The depth of micro-needling was 1.5 mm and 1.75 mm for the upper and lower cheek, respectively. The overlap between shots was 10%, and the number of shots was
s cheeks size.,The normal saline solution of 1 ml was applied to the randomized treatment side of the participant&#039
s cheeks size.
Experimental Procedure/Surgery,Placebo Comparator Procedure/Surgery
Botulinum toxin,Control

Sponsors

Department of Dermatology, Faculty of Medicine Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 50 Years

Inclusion criteria

Inclusion criteria: participants with visible topographic enlarged facial pores confirmed by a dermatologist

Exclusion criteria

Exclusion criteria: 1. photosensitive dermatoses, Skin malignancy, keloid, immunocompromised host, dermatitis or infection at the treatment area 2. regular smoking 3. Pregnancy and lactating woman first 3 months 4. Cannot come back for follow up 5. AHA, retinoic acid, or topical agents for acne scar within 6 months 6. Laser, RF within 3 months 7. Systemic steroid, immunosuppressive agents within 6 months 8. Oral isotretinoin within 12 months

Design outcomes

Primary

MeasureTime frame
Facial pores size at 2 weeks, 1 months, 3 months and 6 months after intervention change in selected area of the facial pore size captured by Antera 3D imaging program

Secondary

MeasureTime frame
Sebum production at 2 weeks, 1 months, 3 months and 6 months after intervention Change in sebum production measured by Sebumeter,Safety at 2 weeks, 1 months, 3 months and 6 months after intervention history tajing and physical examination

Countries

Thailand

Contacts

Public ContactRungsima Wanitphakdeedecha

Faculty of Medicine Siriraj Hospital, Mahidol University

rungsima.wan@mahidol.ac.th0816406300

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026