Facial aging (dynamic wrinkles, skin quality deterioration) Other
Conditions
Interventions
Participants are randomized using a computer-generated random sequence in a split-face design, with one side of the face receiving intradermal botulinum toxin type A (BoNT-A) monotherapy and the contr
Sponsors
Mutah University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 35 to 55 years 2. Presence of mild to moderate dynamic facial wrinkles (e.g., forehead, periorbital, perioral, or nasolabial folds) 3. Early signs of skin laxity and reduced dermal quality (e.g., hydration, tone, or radiance) 4. Willingness to refrain from other facial aesthetic treatments during the study period 5. Ability and willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior facial aesthetic procedures (botulinum toxin, dermal fillers, laser, or energy-based devices) within the past 6 months 2. Active dermatological conditions affecting the face (e.g., eczema, psoriasis, acneiform eruptions, or infections) 3. Known hypersensitivity or allergy to botulinum toxin type A or hyaluronic acid–based products 4. Neuromuscular disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome) 5. History of bleeding disorders or current use of anticoagulant/antiplatelet therapy that may increase injection-related risk 6. Pregnancy or breastfeeding 7. Any systemic illness or unstable medical condition judged by investigators to pose a safety concern or interfere with study outcomes 8. Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in wrinkle severity scores, comparing BoNT-A monotherapy versus BoNT-A + NCTF®135HA (split-face design), will be measured using the Wrinkle Severity Rating Scale (WSRS) between baseline (Day 0) and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change in hydration, firmness, radiance, and tone homogeneity will be patient- and evaluator-reported using a Visual Analog Scale (VAS) from baseline to Day 60 2. Global aesthetic improvement in appearance will be measured by a blinded evaluator and patient using the Global Aesthetic Improvement Scale (GAIS) at Day 60 for each treatment side 3. The proportion of participants reporting visible side-to-side differences, satisfaction, willingness to repeat treatment, and likelihood of recommending it will be measured using a patient satisfaction questionnaire at Day 60 4. The incidence and type of treatment-related adverse events (e.g., bruising, swelling, erythema, tightness) will be measured using case report forms up to Day 60 | — |
Countries
Jordan
Contacts
Public ContactIslam Alzayadneh
Outcome results
None listed