Facial seborrheic dermatitis Facial seborrheic dermatitis, botulinum toxin A
Conditions
Interventions
One side: Received a total maximum dose of up to 32 units of Incobotulinumtoxin type A (Xeomin
Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany), depending on the extent of the lesions, with injection points spaced 1 centimeter apart. The toxin was injected around the lesions at 1 unit per
botulinum toxin A and ketoconazole cream,ketoconazole cream
Sponsors
Strategic Wisdom and Research Institute
Merz Aesthetics Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years. 2. The volunteers have acute-phase seborrheic dermatitis lesions symmetrically on both sides of the face, with disease severity assessed by an mSEDASI score at least 8 and/or experiencing at least 3 flare-ups per year. 3. Participate in the project voluntarily and sign the consent. 4. Able to follow-up examination.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation. 2. Facial skin infection e.g. bacteria, virus or fungal. 3. Other dermatology disease e.g. acne (moderate to severe), dermatitis, rosacea, psoriasis. 4. Treatment of seborrheic dermatitis in 4 weeks before participate the project- corticosteroid (topical and systemic), antifungal, topical calcineurin inhibitor. 5. Treatment of seborrheic dermatitis in 6 months before participate the project- isotretinoin. 6. Received an injection of botulinum toxin A within 6 months before the study. 7. History of botulinum toxin A allergy or allergy to any ingredients in botulinum toxin type A. 8. History of botulinum toxin A resistance. 9. History of topical anesthesia cream allergy. 10. History of neuromuscular disorders such as myasthenia gravis, Lambert-Eaton syndrome and body dysmorphic disorder. 11. History of blood disorders, a tendency to bleed easily, or those taking medications that increase the risk of bruising or bleeding at the injection site such as aspirin, anticoagulants, or fish oil. 12. History of immunodeficiency disorders or cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| facial seborrheic dermatitis baseline, week 2, 4, 8, 12 and 16 after treatment assessing modified SEborrheic Dermatitis Area and Severity Index (mSEDASI) by investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| facial seborrheic dermatitis week 2, 4, 8, 12 and 16 after treatment Patient Global Assessment (PGA) by a volunteer ,Sebum level baseline, week 2, 4, 8, 12 and 16 after treatment sebumeter,Erythema index baseline, week 2, 4, 8, 12 and 16 after treatment mexameter,Pruritus score baseline, week 2, 4, 8, 12 and 16 after treatment visual analog scale,Pain score baseline, week 2, 4, 8, 12 and 16 after treatment visual analog scale,Adverse effects (e.g. erythema, edema, bruising, facial asymmetry and brow ptosis) immediate after treatment, week 2, 4, 8, 12 and 16 after treatment by investigator,Adverse effects (e.g. erythema, edema, bruising, facial asymmetry and brow ptosis) immediate after treatment, week 2, 4, 8, 12 and 16 after treatment Patient report | — |
Countries
Thailand
Contacts
Public ContactPintusorn Kungvalpivat
Department of Dermatology, Faculty of Medicine, Srinakharinwirot University
Outcome results
None listed