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Efficacy and optimized dosage of botulinum toxin type A injection for treatment of Acne vulgaris, enlarged pore, and oiliness: A randomized placebo-controlled trial

Efficacy and optimized dosage of botulinum toxin type A injection for treatment of Acne vulgaris, enlarged pore, and oiliness: A randomized placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231025002
Enrollment
75
Registered
2023-10-25
Start date
2024-06-20
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Patients with moderate acne vulgaris Botulinum toxin type A, acne vulgaris, enlarged pore, oiliness

Interventions

Normal saline injection 0.3 ml at forehead,Botulinum toxin type A 6 unit (dilution 1:5) injection 0.3 ml at forehead,Botulinum toxin type A 12 unit (dilution 1:2.5) injection 0.3 ml at forehead
Botulinum toxin type A 0 unit,Botulinum toxin type A 6 unit,Botulinum toxin type A 12 unit

Sponsors

Srinakharinwirot University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Healthy patients age 18 to 45 years old, 2. Patients with moderate acne vulgaris according to Clinical practice guideline of acne of Dermatological society of Thailand, 3. Consent to study

Exclusion criteria

Exclusion criteria: 1. Received a forehead injection of botulinum toxin within 6 months before the study, 2. Received a forehead injection of hyaluronic acid (HA), biostimulator, or mesotherapy within 6 months before the study, 3. Received the systemic treatments before the study (3.1 Anti-inflammatory drugs or drugs that have an effect on the treatment of acnes such as oral corticosteroids, oral antibiotics, oral contraceptive pills or oral zinc supplement within 1 month before the study, 3.2 Drugs in retinoid group such as oral isotretinoin within 3 months before the study), 4. Received the topical drugs for acne such as topical antibiotics, topical retinoids, or topical corticosteroids within 1 month before the study, 5. History of botulinum toxin A allergy or allergy to any ingredients in botulinum toxin type A, 6. History of botulinum toxin A resistance, 7. History of neuromuscular disorders such as myasthenia gravis, Lambert-Eaton syndrome, 8. Current or active facial bacterial, fungal, or viral infection, 9. Pregnancy or lactation, 10. Cannot follow up throughout the study period

Design outcomes

Primary

MeasureTime frame
Acne vulgaris at baseline and at 2, 4, 8, 12, and 16 weeks after the intervention modified Total acne lesion count

Secondary

MeasureTime frame
Acne vulgaris at baseline and at 2, 4, 8, 12, and 16 weeks after the intervention Modified Global acne severity scale,Acne vulgaris at baseline and at 2, 4, 8, 12, and 16 weeks after the intervention modified Michaelson acne score,Pores size at baseline and at 2, 4, 8, 12, and 16 weeks after the intervention Pore size volume by Antera 3D,Sebum level at baseline and at 2, 4, 8, 12, and 16 weeks after the intervention Sebum level and percentage of sebum reduction by Sebumeter,Patient satisfaction score at 4 and 16 weeks after the intervention Visual analogue scale,Adverse effects at 2, 4, 8, 12, and 16 weeks after the intervention Skin infection, erythema, edema, bruising, facial asymmetry, and brow ptosis

Countries

Thailand

Contacts

Public ContactVatanya Rungtiravatananon

Srinakharinwirot university

vatanya.nuk@gmail.com0894493437

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026