Efficacy and optimized dosage of botulinum toxin type A injection for treatment of Acne vulgaris, enlarged pore, and oiliness: A randomized placebo-controlled trial
- Conditions
- Patients with moderate acne vulgarisBotulinum toxin type A, acne vulgaris, enlarged pore, oiliness
- Registration Number
- TCTR20231025002
- Lead Sponsor
- Srinakharinwirot University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 75
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acne vulgaris at baseline and at 2, 4, 8, 12, and 16 weeks after the intervention modified Total acne lesion count
- Secondary Outcome Measures
Name Time Method 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