NCT03097835

Evaluation of Skin Quality Improvement

Evaluation of Skin Quality Improvement When Hyper-Diluted OnabotulinumtoxinA (Botox®, Botox® Cosmetic /BTXa/) is Injected Into The Superficial Dermis of the Mid-Face

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Steve Yoelin M.D. Medical Associates, Inc. · Academic / Other
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to comprehensively investigate and objectively demonstrate the effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more specifically evenness of skin tone, reduction of pore size and improvement in the appearance of preexisting skin scars.

Detailed description

The purpose of this study is to comprehensively investigate and objectively demonstrate the effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more specifically evenness of skin tone, reduction of pore size and improvement in the appearance of preexisting skin scars. The ability of hyperdilute Botox® Cosmetic to improve overall skin quality is likely optimized when it is injected uniformly in hyper-diluted small aliquots in order to "saturate" the dermis. We propose to prepare Botox® Cosmetic in a manner that is approximately 4 times more dilute compared to the typical Botox® Cosmetic preparation. A 4x4 centimeter area located in the mid-cheek adjacent to the nose will be injected with hyperdilute Botox® Cosmetic. Botox® Cosmetic is not FDA-approved for this use. A maximum of 15 subjects will participate in this study, all of whom will receive injections of Botox® Cosmetic during the course of this study. This study is a randomized, placebo-controlled, and double-masked study. This means neither the study doctor nor participant know the experimental agent (e.g., 0.9% saline solution and hyperdiluted Botox® Cosmetic) injected on each side of the patients' faces. The study will last for a total of 75 days. Evaluation of the study is based on the analysis of photographic images obtained during the study.

Conditions

• Skin Quality

Interventions

Type	Name	Description
DRUG	Hyper-Diluted Botox	0.1ml of hyper-diluted Botox® Cosmetic will be administered in the superficial dermis using a 1ml luer lock syringe coupled with a 33g ½" needle
DRUG	Topical anesthesia	Topical anesthesia will be bilaterally applied to the mid-face region for 20 minutes
OTHER	0.9% saline solution	0.1ml of 0.9% saline solution will be administered to the side of the face

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-07-12
• Completion: 2018-07-26
• First posted: 2017-03-31
• Last updated: 2019-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study