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

Part of paid clinical trials in Cisco, Texas.

Sponsor
Global Aesthetics LLC
Study ID
NCT06385171
Status
Recruiting
Apply to this trial

Conditions

  • Wrinkle

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Botulinum toxin type A — DRUG
    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 Details

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.

Key Dates

Start date
May 22, 2024
Status verified
May 2024
Primary completion
Jun 1, 2026
Completion
Jan 5, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in facial wrinkles and Lines [ Time Frame: Upto 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Global Aesthetics LLCCiscoTexas76437
Otis Scroggins, BS, CNA
[email protected]
806-370-7428
Otis Scroggins, BS, CNA (PRINCIPAL_INVESTIGATOR)
Global Aesthetics LLCLubbockTexas79413
Otis Scroggins, BS, CNA
[email protected]
806-370-7428

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