Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-01-20
2025-09-30
Brief Summary
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Comparison of the placebo- and BOTOX®-treated participant scores will either support or disprove the study hypothesis.
Qualified participants who meet the study requirements, including a one-time completion of basic laboratory testing before treatment.
The treatment visit starts on day-1 of a 12-week period, which consists a total of four clinic visits and one online visit, which involve:
* vital signs and Body Mass Index (BMI) measurements
* basic/interval history and physical
* 2 Perceived Stress Scale (PSS) questionnaires
* injection of 64 units of either BOTOX® or sterile salt solution
* stay for 60-minutes after treatment for monitoring and to complete study tasks
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Detailed Description
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\* Intervention type is masked for both the participant and the treating physician. However, this is subject to change in the case of adverse reactions or events.
Please contact study affiliates for additional information.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Saline
Sterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only
Intramuscular injection
Injection performed using method for aesthetic facial rejuvenation procedure with neuromuscular chemodenervation agents
Sodium Chloride
Placebo injection of the same volume of preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only.
OnabotulinumtoxinA (BOTOX®) injection
Active drug reconstituted with sterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only
Intramuscular injection
Injection performed using method for aesthetic facial rejuvenation procedure with neuromuscular chemodenervation agents
OnabotulinumtoxinA (Botox®) Injections
Injection of 64 units of active drug at a ratio of 4 units to 0.1 mL of sterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only
\- Abbvie/Allergan drug.
Interventions
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Intramuscular injection
Injection performed using method for aesthetic facial rejuvenation procedure with neuromuscular chemodenervation agents
OnabotulinumtoxinA (Botox®) Injections
Injection of 64 units of active drug at a ratio of 4 units to 0.1 mL of sterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only
\- Abbvie/Allergan drug.
Sodium Chloride
Placebo injection of the same volume of preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Females 18-65 years of age
3. Perceived Stress Scale (PSS) ≥ 14 at screening.
4. Participants who have been toxin-naive for ≥1 year (i.e. onabotulinumtoxinA (BOTOX®), alternatives, or its derivatives)
5. Female subjects willing to minimize the risk of inducing pregnancy for the duration of clinical study
6. Subjects in good physical and mental health and not on any prescription psychiatric medications
7. Subjects willing to not undergo any other aesthetic or skin treatments for the duration of the study
Exclusion Criteria
2. Use of neuromodulators in the past ≤ 12 months
3. History or known alcohol and/or illicit drug abuse
4. Participants with psychiatric diagnosis
5. Body Mass Index (BMI) at Screening ≥ 30 kg/m2.
6. Participants with metabolic disorders (e.g., hypothyroidism and hyperparathyroidism)
7. Undiagnosed, unstable, or preexisting conditions that in the opinion of the investigators, would interfere with the course and conduct of the study. These include but are not limited to inflammatory disorders, diseases that affect muscles and/or nerves such as myasthenia gravis and Lambert-Eaton syndrome, high blood pressure, heart disease, and/or stroke that could result in a life-threatening response when treated with BOTOX® or placebo.
8. Participant has any laboratory abnormality (found on screening) that, in the opinion of the investigators, is clinically significant, has not resolved at baseline and could jeopardize or would compromise the participant's ability to participate in this study.
9. Prior use of isotretinoin
10. Active skin disease or infection at or near injection sites
11. Active use of tobacco or nicotine products in any form via any route (e.g. inhalation, ingestion, absorption)
12. Chronic marijuana or tetrahydrocannabinol exposure
13. If the investigators feel that the subject is not a good candidate for the study
14. Females of childbearing potential not using a reliable means of contraception
15. Female subjects must not be breastfeeding
16. Any known previous hypersensitivity reactions to BOTOX®
17. Current or recent (within therapeutic window) use of neuromuscular medications that may pose additional risk with treatment with BOTOX®, such as but not limited to amino-glycosides and anticholinergic drugs
18 Years
65 Years
FEMALE
Yes
Sponsors
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Center for Advanced Facial Plastic Surgery
OTHER
Responsible Party
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Principal Investigators
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Babak Azizzadeh, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Center for Advanced Facial Plastic Surgery
Marielle He, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Center for Advanced Facial Plastic Surgery
Locations
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Center for Advanced Facial Plastic Surgery
Beverly Hills, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MTIIT-955A
Identifier Type: -
Identifier Source: org_study_id
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