--- title: Microbotox for Lower Face Rejuvenation nct_id: NCT03189082 overall_status: COMPLETED phase: NA sponsor: St Joseph University, Beirut, Lebanon study_type: INTERVENTIONAL primary_condition: Botulinum Toxin countries: Lebanon canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03189082.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03189082" ct_last_update_post_date: 2017-10-06 last_seen_at: "2026-05-12T06:56:22.973Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Microbotox for Lower Face Rejuvenation **Official Title:** "Microbotox" Versus Intramuscular Botulinum Toxin in Lower Face Rejuvenation: A Crossover Clinical Trial **NCT ID:** [NCT03189082](https://clinicaltrials.gov/study/NCT03189082) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 15 - **Lead Sponsor:** St Joseph University, Beirut, Lebanon - **Conditions:** Botulinum Toxin, Rejuvenation, Therapy, Neck - **Start Date:** 2017-08-10 - **Completion Date:** 2017-10-04 - **CT.gov Last Update:** 2017-10-06 ## Brief Summary The purpose of this study is to evaluate the efficiency of the intradermal injection of botulinum toxin in lower face rejuvenation. The study will also compare this intervention with the "Nefertiti Lift" intramuscular injection technique. ## Detailed Description The abobotulinumtoxinA will be used for the intervention. The abobotulinumtoxinA will be prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial. Further dilution to the appropriate Microbotox concentration will be done in the syringe itself. Each 1mL syringe of Microbotox solution will contain 20-28 units of onabotulinumtoxinA per mL of solution. Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction) Injection points: A series of 100-150 intradermal microdroplets injection points 1 cm apart will be delivered in the lower face. The area to be injected is bounded by a line 3 fingerbreadths above and parallel to the lower border of the mandible, 1 fingerbreadth posterior to the depressor anguli oris, and all the way down over the cervicomental angle and anterior neck to the upper border of the clavicle, and posteriorly to the anterior border of the sternocleidomastoid. In the average patient, 2 syringes of 28 units per mL of microbotox will be used to cover the entire area. In heavier necks, 3 syringes of 28 units per mL will be used. In thinner necks, 2 syringes of 20 units per mL will be used. Follow up will be done at 15 days for post injection pictures. A total of 15 patients will be recruited ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 90 Years - **Sex:** FEMALE - **Healthy Volunteers:** Yes ``` Inclusion Criteria: Female patients presenting to our clinic for neck rejuvenation who: * Were deemed nonsurgical candidates for neck rejuvenation * Were not willing to undergo invasive surgical procedures * Had a medical contraindication to surgery Exclusion Criteria: * Patients with lower face botulinum toxin injection in the past 12 months * Patients with resorbable lower face fillers injection in the past 12 months * Patients with previous permanent lower face fillers injection * Pregnant patients * Lactating patients * Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome) * Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics) * Patients with sensitivity to botulinum toxin or human albumin ``` ## Arms - **Intervention group** (EXPERIMENTAL) ## Interventions - **Microbotox** (PROCEDURE) — Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face ## Primary Outcomes - **Neck volume using a validated scale from the Summit Scale II** _(time frame: 15-25 days post treatment)_ — The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos. 1. No Sagging 2. Mild Sagging 3. Moderate Sagging 4. Severe Sagging 5. Very Severe Sagging - **Jowls at rest using a validated scale from the Summit Scale II** _(time frame: 15-25 days post treatment)_ — The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos 1. No Sagging 2. Mild Sagging 3. Moderate Sagging 4. Severe Sagging 5. Very Severe Sagging - **Marionette lines at rest using a validated scale from the Summit Scale II** _(time frame: 15-25 days post treatment)_ — The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos 1. No visible folds: continuous skin lines 2. Shallow but visible folds with slight indentation 3. Moderately deep folds, clear feature at normal appearance, but not when stretched 4. Very long and deep folds, prominent facial feature 5. Extremely long and deep folds; detrimental facial appearance - **Oral commissures at rest using a validated scale from the Summit Scale II** _(time frame: 15-25 days post treatment)_ — The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos 1. No Downturn 2. Mild Downturn 3. Moderate Downturn 4. Severe Downturn 5. Very Severe Downturn - **Platysmal bands at maximal contraction using a validated scale** _(time frame: 15-25 days post treatment)_ — The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. The 3 evaluators will be blinded to the pre or post injection status of the photos 1. No relevant prominence of platysmal bands 2. Mild prominence of platysmal bands 3. Moderate prominence of platysmal bands 4. Severe prominence of platysmal bands 5. Very severe prominence of platysmal bands - **Platysmal bands at rest using a validated scale** _(time frame: 15-25 days post treatment)_ — The assessment will be done by 3 plastic surgeons. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale. 1. No platsymal bands visible at rest 2. Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck. 3. Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue. 4. Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue. 5. Severe platsymal bands along the full length of the neck at rest, elevation at least 5 mm from the surrounding tissue, with additional soft tissue ptotic banding present laterally - **Mandibular definition change with maximal contraction will be assessed by a 2-point scale** _(time frame: 15-25 days post treatment)_ — The assessment of the pre-injection photos will be done by 3 plastic surgeons. 1. Mandibular contour does not worsen with platysmal contraction 2. Mandibular contour worsen with platysmal contraction ## Secondary Outcomes - **Investigators Global Aesthetic Improvement Scale** _(time frame: 15-25 days post treatment)_ - **Subject Global Aesthetic Improvement Scale** _(time frame: 15-25 days post treatment)_ - **Patient satisfaction** _(time frame: 15-25 days post treatment)_ - **Patient willingness to repeat the procedure** _(time frame: 15-25 days post treatment)_ - **Patient willingness to recommend the procedure** _(time frame: 15-25 days post treatment)_ - **Assessment of Pain during treatment** _(time frame: Immediately after the treatment)_ ## Locations (1) - Hotel Dieu De France, Beirut, Aschrafieh, Lebanon ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hotel dieu de france|beirut|aschrafieh|lebanon` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03189082.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03189082* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*