WithdrawnNot Applicable

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

Stopped: Study did not begin, and no participants were enrolled.

United States0Started 2024-05-22

Plain-language summary

A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in facial wrinkles and Lines

Timeframe: Upto 2 years

Facial Appearance

Timeframe: Upto 2 years

Assessment of Wrinkle Severity

Timeframe: Upto 2 years

Trial details

NCT IDNCT06385171

SponsorGlobal Aesthetics LLC

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Wrinkle trials

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.