WrinkleNCT06385171
Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
An observational study of Wrinkle, run by Global Aesthetics LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Wrinkle
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2024to 5 Jan 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Global Aesthetics LLC
Cisco, Texas, 76437
Global Aesthetics LLC
Lubbock, Texas, 79413
About this study
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.
Read the 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.
- Conditions
- Wrinkle
- Being tested
- Botulinum toxin type A
- Keywords
- Facial Wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called OnabotulinumtoxinA
The intervention involves the administration of Botulinum Toxin Type A, with dosages regulated according to FDA guidelines. Each injection site will receive a maximum of 4 units, adhering to the FDA's recommended dosage limits. Dosages administered will be tailored to each patient's needs and will be recorded in their individual patient information chart.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental: Botulinum Toxin Type A:
Patients will receive their first treatment on Day 1 after screening, with baseline facial muscle assessment on Day 0. Touch-up treatments will be given every 3 weeks until the sixth month. At Week 3, primary efficacy assessment will be conducted by evaluating facial movement control. Longevity assessment will occur at Month 6, with additional evaluation of immune response. This cycle will repeat for the second dose after six months until one year, and the same cycle will repeat for the 2nd dose. Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in facial wrinkles and Lines
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.
Measured: Upto 2 years
Facial Appearance
Patients will provide feedback on their satisfaction with the treatment outcome and perceived changes in their facial appearance.
Measured: Upto 2 years
Assessment of Wrinkle Severity
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.
Measured: Upto 2 years
Secondary outcomes (1)
Assessment of Skin Reaction
The Principal Investigator (PI) will measure the presence and severity of skin reactions using a grading scale, where:
Grade 0 represents no skin reaction, Grade 1 represents mild redness or inflammation, Grade 2 represents moderate redness or inflammation, and Grade 3 represents severe redness, inflammation, or swelling. By assigning a numerical value to skin reactions, the PI will quantify the degree of immune response, allowing for measurable comparisons over time.
Measured: Upto 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start22 May 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Why it stopped: Study did not begin, and no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Aesthetics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Otis Reid Scroggins, Global Aesthetics LLC
- Investigators
- Otis Scroggins, BS, CNA, Principal investigator, Global Aesthetics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385171
- Sponsor's protocol ID
- FFA-BTX-1
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The reason for this decision is due to ongoing considerations regarding data privacy, ethical considerations, and the need for further consultation with relevant stakeholders, including participants and regulatory bodies.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation
- ClinicalTrials.gov ID
- NCT06385171
- Acronym / sponsor ID
- FFA-BTX-1
- Conditions
- Wrinkle
- Keywords
- Facial Wrinkles
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not begin, and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Global Aesthetics LLCUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | – | Drug: Botulinum toxin type AExperimental: Botulinum Toxin Type A: Patients will receive their first treatment on Day 1 after screening, with baseline facial muscle assessment on Day 0. Touch-up treatments will be given every 3 weeks until the sixth month. At Week 3, primary efficacy assessment will be conducted by evaluating facial movement control. Longevity assessment will occur at Month 6, with additional evaluation of immune response. This cycle will repeat for the second dose after six months until one year, and the same cycle will repeat for the 2nd dose. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: OnabotulinumtoxinAThe intervention involves the administration of Botulinum Toxin Type A, with dosages regulated according to FDA guidelines. Each injection site will receive a maximum of 4 units, adhering to the FDA's recommended dosage limits. Dosages administered will be tailored to each patient's needs and will be recorded in their individual patient information chart. | Drug | Single Group Assignment |
Primary outcome
Change in facial wrinkles and Lines
Time frame: Upto 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 Appearance
Time frame: Upto 2 years
Patients will provide feedback on their satisfaction with the treatment outcome and perceived changes in their facial appearance.
Assessment of Wrinkle Severity
Time frame: Upto 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.
1 secondary outcome
Assessment of Skin Reaction
Time frame: Upto 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided. The reason for this decision is due to ongoing considerations regarding data privacy, ethical considerations, and the need for further consultation with relevant stakeholders, including participants and regulatory bodies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Otis Scroggins, BS, CNA principal investigator
Global Aesthetics LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkle, run by Global Aesthetics LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in facial wrinkles and Lines (time frame: Upto 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.