Clinical trial NCT06385171: Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
Official title: Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wrinkle
Keywords: Facial Wrinkles
Lead sponsor: Global Aesthetics LLC
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population from which the groups or cohorts will be selected consists of individuals aged between 20 and 65 years, regardless of gender, who are seeking treatment for facial wrinkles. These individuals must be in good physical health and exhibit both static (unchanging) and moderate dynamic (movement-induced) wrinkles on the forehead or glabellar region. They should also possess the willingness and ability to understand and provide informed consent for participation in the study. This population may include individuals from various backgrounds and demographics who are interested in cosmetic dermatology procedures.

Brief 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.

Detailed description: The primary purpose of this clinical trial is to evaluate the efficacy and safety of Botulinum Toxin Type A in the treatment of facial wrinkles among a diverse population, with a specific aim to bridge the gap between cosmetic injectables and varying financial statuses of potential patients. This study intends to determine the degree to which Botulinum Toxin Type A can reduce the appearance of facial wrinkles, identify the optimal dosage for significant cosmetic improvement with minimal side effects, and assess patient satisfaction with the outcomes. By conducting a rigorous, controlled, and open label methodology, this research aspires not only to provide comprehensive data supporting the use of Botulinum Toxin Type A as a safe and effective treatment for aesthetic improvement but also to make such treatments more accessible and affordable. This endeavor seeks to democratize cosmetic enhancements, ensuring that individuals across different economic backgrounds can benefit from advancements in cosmetic dermatology. Ultimately, the study aims to offer valuable insights into cost-effective practices without compromising treatment quality, thereby enhancing patient care practices and contributing significantly to the field of cosmetic dermatology.

Eligibility criteria: 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 study protocol or provide informed consent.

Primary outcomes:
measure: Change in facial wrinkles and Lines
timeFrame: Upto 2 years
measure: Facial Appearance
timeFrame: Upto 2 years
measure: Assessment of Wrinkle Severity
timeFrame: Upto 2 years
Secondary outcomes:
measure: Assessment of Skin Reaction
timeFrame: Upto 2 years
Other outcomes:
Locations:
city: Cisco
country: United States
facility: Global Aesthetics LLC
state: Texas
city: Lubbock
country: United States
facility: Global Aesthetics LLC
state: Texas
Study officials:
affiliation: Global Aesthetics LLC
name: Otis Scroggins, BS, CNA
role: PRINCIPAL_INVESTIGATOR
References: