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Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation

{ "Observational Study of Botulinum Toxin Type A for Facial Wrinkles", "This study is looking at how well Botulinum Toxin Type A (often called Botox) works to reduce facial wrinkles. Researchers want to see if this treatment is safe and effective for making wrinkles on your forehead or between your eyebrows less noticeable. They also want to find the best dose and make these treatments more affordable. You might be able to join if you are between 20 and 65 years old, in good health, and have both static (always there) and dynamic (when you move your face) wrinkles. The study will measure changes in your wrinkles and how your face looks for up to two years. The current recruitment status is unclear, but they plan to enroll 500 people.", "design": "This is an observational study that plans to enroll 500 participants. It is an open-label study, meaning both you and the researchers will know you are receiving Botulinum Toxin Type A.", "commitments": "You will receive injections of Botulinum Toxin Type A, with each injection site getting a maximum of 4 units. Your facial wrinkles and appearance will be assessed for up to two years.", "compensation": "Not stated in the trial record.", "follow_up": "Your facial wrinkles, appearance, and wrinkle severity will be assessed for up to two years after the treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06385171

Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation

Withdrawn
Not specifiedAges 20–65Observational
Global Aesthetics LLC
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Botulinum toxin type A

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in facial wrinkles and Lines
Measured over Upto 2 years
+2 more outcomes measured

Conditions

Wrinkle

Explore related trials

Wrinkled face

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Otis Scroggins, BS, CNA · PRINCIPAL_INVESTIGATOR · Global Aesthetics LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals of both genders.
Must be in good physical health.
Age between 20 and 65 years.
Presence of both static (unchanging) and moderate dynamic (movement-induced) wrinkles on the forehead or glabellar region.
Must possess the willingness and ability to understand and provide informed consent, as well as effectively communicate with study personnel.

Exclusion

Pregnant or breastfeeding female.
Age below 20 or above 65 years.
History of neuromuscular disorders, such as myasthenia gravis.
History of facial surgery or presence of scars in the treatment area that could potentially interfere with or confound the results of the study.
Recent treatment history within the past 6 months in the forehead or glabellar region, including:
Ablative laser procedures.
Radiofrequency device treatments.
Ultrasound device treatments.
Medium to deep chemical peels.
Temporary soft tissue augmentation.
Semi-permanent soft tissue augmentation within the past 2 years.
Permanent soft tissue augmentation.
Planned cosmetic procedures within the next 6 months in the same region.
Intended use of tretinoin or retinoic acid within the next 6 months.
Presence of active infection in the treated area, excluding mild acne.
Allergy to cow's milk protein or albumin.
Use of aminoglycoside medications.
Current use of anticoagulation therapy.
History of bleeding disorders.
Diagnosis of mental illness.
Inability to comprehend the study protocol or provide informed consent.

What this trial measures

  • Change in facial wrinkles and LinesUpto 2 years

    Visual Assessment: The Principal Investigator (PI) will visually assess the change in wrinkles and lines on the patient's face compared to baseline, using the following grading scale: Grade 0: No improvement in wrinkles. Grade 1: Minimal improvement, slight reduction in wrinkles. Grade 2: Moderate improvement, noticeable reduction in wrinkles. Grade 3: Significant improvement, substantial reduction in wrinkles. Assessment of Change in Wrinkles and Lines: Photographic Documentation: Before and after photographs will be taken to objectively compare the appearance of facial wrinkles and lines. The improvement will be graded using the following scale: Grade 0: No change or worsening of wrinkles. Grade 1: Slight improvement, minimal reduction in wrinkles. Grade 2: Moderate improvement, visible reduction in wrinkles. Grade 3: Significant improvement, marked reduction in wrinkles.

  • Facial AppearanceUpto 2 years

    Patients will provide feedback on their satisfaction with the treatment outcome and perceived changes in their facial appearance.

  • Assessment of Wrinkle SeverityUpto 2 years

    The WSRS will rate the severity of wrinkles on a scale of 1 to 5, with 1 indicating no wrinkles and 5 indicating severe wrinkles.