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The efficacy of botulinum toxin A delivered via reservoir-backed microneedle patch for facial sebum reduction compared to normal saline: a randomized, split-face pilot clinical trial

The efficacy of botulinum toxin A delivered via reservoir-backed microneedle patch for facial sebum reduction compared to normal saline: a randomized, split-face pilot clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260401021
Enrollment
16
Registered
2026-04-01
Start date
2026-03-28
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

Healthy Thai adult aged 18 to 40 years with oily facial skin Oily skin, Seborrhea, botulinum toxin A, resorvoir-backed microneedle patch, microneedle patch

Interventions

20 unit(1ml) of botulinum toxin A delivered via resorvoir- backed microneele patch at one side of narsal dorsum and cheek, applied for 15 minutes,1 ml of normal saline delivered via resorvoir- backed
Experimental Drug,Placebo Comparator No treatment
Botulinum toxin A delivered via resorvoir-backed microneedle patch,Normal saline delivered via resorvoir-backed microneedle patch

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Healthy Thai adult aged 18-40 years 2. Clinical oily facial skin with 15 or more of Six-item skin oiliness scale score 3. Elevated baseline ebum level at nasal dorsum and cheek morethan 106 microgram per square centimeters 4. Willing to refrain from using othe sebum reduction treatment during study period 5. Provided informed consent form

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women 2. Active local skin infections 3. Botulinum toxin A allergy or hypersensitivity reaction 4. Neuromuscular disease e.g. MG, LE, MS 5. Immunodeficiency 6. History of coagulopathy or anti-coagulant medication 7. History of keloid or hypertrophic scar 8. Current use of topical sebum reduction product or treatment in the past 1 month 9. Current use of Isotretinoin, spironolactone or oral contraceptive in the past 3 months 10. Current use of aminoglycosides, succinylcholine, cyclosporine, D-penicillamine, quinidine, aminoquinolones, magnesium sulfate, lincosamides 11. Botulinum toxin A injection, photodynamic therapy or laser treatment in the past 3 months 12. Unable to read or write in Thai

Design outcomes

Primary

MeasureTime frame
Sebum level At 1 month and 4 months after end of the intervention Sebumeter

Secondary

MeasureTime frame
Feature count of pore At 1 month and 4 months after end of the intervention VISIA 7th generation,Quality of life At 1 month and 4 months after end of the intervention Oily skin self-image questionnaire ,Patient satisfaction At 1 month and 4 months after end of the intervention Likert satisfaction scale,Adverse event At postintervention, 48 hours, 1 month and 4 months after end of the intervention Visual analogue scale

Countries

Thailand

Contacts

Public ContactPantira Dheerachaikulpanich

Dhurakij Pundit University

67130412@dpu.ac.th029547300

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026