melasma melasma
Conditions
Interventions
Letibotulinum toxin A at a concentration of 20 units per 1 ml, prepared by diluting 100 international units of Botulinum toxin A in 5 ml of 0.9% normal saline (1:5 dilution),Letibotulinum toxin A at a
Active Comparator Drug,Experimental Drug
Letibotulinum toxin A 1:5 dilution ,Letibotulinum toxin A 1:10 dilution
Sponsors
Faculty of Medicine Siriraj hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Thai Male or Female, age 18-65 years old 2. Have mixed-type and epidermal-type Melasma on both side of face 3. Subject must not be treated melasma by using topical cream, laser, or medication for 6 months prior
Exclusion criteria
Exclusion criteria: 1. History of receiving anti-inflammatory or anticoagulant medication within 72 hours prior to treatment. 2. Medical history of autoimmune diseases, allergies, immunodeficiency, myopathy, history of organ transplantation, or cancer. 3. Pregnancy, postpartum within 3 months, or breastfeeding individuals, assessed through menstrual history and contraceptive methods. 4. Individuals with skin diseases or infections in the study area. 5. Received Botulinum toxin injection within the last 6 months before participating in the research project. 6. Received facial biostimulators and fillers within the last 12 months before joining the research project. 7. Inability to adhere to the research project details throughout the study duration. 8. Medical history of abnormal blood clotting or abnormal blood coagulation, anemia, or liver disease. 9. History of hormone use, including topical, oral, injectable, or implantable hormones, within the last 6 months before joining the research project. 10. Regular outdoor activities without sun protection after joining the research project. 11. History of using vitamin E or skin-lightening agents within 1 month before joining the research project. 12. History of using hydroquinone within 6 months before joining the research project. 13. Use of steroid creams on face area within 3 months or oral steroid use within 2 weeks before joining the research project. 14. History of laser treatment on the face within 6 months before joining the research project. 15. Use of photosensitive medications, such as tetracycline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effectiveness and safety of two different concentrations of Botulinum toxin A as a novel treatment for melasma baseline, 2-week after treatment, and 1,2,4,6-month after treatment mMASI score, brown spots and red areas measured by VISIA complexion analysis (Canfield Scientific, Inc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| the effectiveness of treatment for enlarged pore size utilizing Botulinum toxin A with two distinct concentrations baseline, 2-week after treatment, and 1,2,4,6-month after treatment mean pore area and mean pore volume by Antera,the effectiveness of reducing sebum production utilizing Botulinum toxin A with two distinct concentrations baseline, 2-week after treatment, and 1,2,4,6-month after treatment sebum level by Sebumeter | — |
Countries
Thailand
Contacts
Public ContactThanya Techapichetvanich
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed