fresh facial scars. Hypertrophic scars.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subject in good health, or with stable treated medical condition, as determined by the investigator. 2 Scheduled to undergo, or recently undergone facial surgery for fracture reduction, or removal of benign tumors, or had fresh facial cutting wounds. 3 wound closure size at least 4 cm in length 4 Willing and able to complete and comply with procedures, protocol requirements, and instructions, including completing all required visits. 5 Willing and able to sign and date the approved informed consent. 6 Able to speak, read, and understand the language of the informed consent form, and study questionnaires.
Exclusion criteria
Exclusion criteria: 1 Pregnant or breastfeeding, or planning a pregnancy. 2 Reported use of any botulinum toxin of any serotype within the last 6 months. 3 Known hypersensitivity to any botulinum toxin serotype. 4 Aminoglycoside intake within 48 hours before or during surgery. 5 Pre-existing neuromuscular junction disorders (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis). 6 Any uncontrolled medical condition that in the opinion of the investigator could put the subject at undue safety risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scar Appearance at time of intervention, one month, 3 months, and 6 months Visual Analogue Scale; Values From 0 (Worst) to 10 (Best) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient and observer scar assessment scale at time of intervention, one month, 3 months, and 6 months values from 0 to 10 for pain, itching, color, texture, thickness, regularity, vascularity, pigmentation, and elasticity. | — |
Countries
Syrian Arab Republic
Contacts
Damascus University in syia