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

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.

Study Overview

• Status: Completed
• Conditions: Skin Quality
• Intervention / Treatment: Drug: Hyper-Diluted Botox; Drug: Topical anesthesia; Other: 0.9% saline solution

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Steve Yoelin MD & Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ability to follow study instructions and likely to complete all required visits
• Written consent has been obtained
• Written authorization for "Use and Release of Health and Research Study Information" has been obtained
• Subjects who are Fitzpatrick Skin Types II-IV

Exclusion Criteria:

• Subjects must be Onabotulinum Toxin Type A naive; if subject has had Onabotulinum Toxin Type A administered in the face in the previous 12 months they are excluded
• Subjects must be dermal filler naïve in the lateral canthal region and midface regions
• Subjects must be energy or light device naïve
• Subjects must have average or below-average lifetime sun exposure
• Subjects must be free of inflammatory skin disease(s)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; Group A will be treated with Hyper-Diluted Botox on day 1 and on day 30 they will be treated with 0.9% saline solution.	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
Other: Group B; Group B will be treated with 0.9% saline solution on day 1 and on day 30 they will be treated with Hyper-Diluted Botox.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Improvement in Skin Quality	An evaluation of the percent improvement in skin quality when the "Onabotulinum Toxin Type A" treated side of face is compared to the "placebo" treated side of the face. Good skin quality is defined as small pore size, evenness of skin texture, evenness of skin tone, minimal presence of wrinkles, and minimal presence of scars. We will measure improvement primarily by image analysis of the photos taken during each visit using the Canfield Scientific camera (or the Allergan provided alternative).	Entire duration of the study (Day 1-Day 135)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and Investigator Reported Outcomes	An objective observer as well as the patient will evaluate if there is an improvement in skin quality throughout the course of the study.	Entire duration of the study (Day 1-Day 135)

Collaborators and Investigators

• Sponsor: Steve Yoelin M.D. Medical Associates, Inc.
• Collaborators: Allergan

Publications and helpful links

General Publications

• Bansal C, Omlin KJ, Hayes CM, Rohrer TE. Novel cutaneous uses for botulinum toxin type A. J Cosmet Dermatol. 2006 Sep;5(3):268-72. doi: 10.1111/j.1473-2165.2006.00255.x.
• Diamond A, Jankovic J. Botulinum toxin in dermatology - beyond wrinkles and sweat. J Cosmet Dermatol. 2006 Jun;5(2):169. doi: 10.1111/j.1473-2165.2006.00250.x. No abstract available.
• Xiao Z, Zhang F, Lin W, Zhang M, Liu Y. Effect of botulinum toxin type A on transforming growth factor beta1 in fibroblasts derived from hypertrophic scar: a preliminary report. Aesthetic Plast Surg. 2010 Aug;34(4):424-7. doi: 10.1007/s00266-009-9423-z. Epub 2009 Oct 3.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): July 26, 2018

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: HDB101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be shared through the form of either a published paper or poster presentation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No