Evaluation of Skin Quality Improvement

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Skin Quality

Intervention / Treatment
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* Drug: Hyper-Diluted Botox
* Drug: Topical anesthesia
* Other: 0.9% saline solution


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This will be a longitudinal study in which patients will be initially treated with hyper-diluted Botox Cosmetic in the superficial dermis or they will be treated 0.9% saline. Then, on day 30 of the study patients initially treated with hyper diluted Botox Cosmetic will be treated with saline and patients initially treated with saline will be treated with hyper-diluted botox.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>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<br>* 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<br>Drug: Topical anesthesia<br>* Topical anesthesia will be bilaterally applied to the mid-face region for 20 minutes<br>Other: 0.9% saline solution<br>* 0.1ml of 0.9% saline solution will be administered to the side of the face<br>|
| Other: Group B<br>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<br>* 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<br>Drug: Topical anesthesia<br>* Topical anesthesia will be bilaterally applied to the mid-face region for 20 minutes<br>Other: 0.9% saline solution<br>* 0.1ml of 0.9% saline solution will be administered to the side of the face<br>|

What is the study measuring?
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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) |