Evaluation of Skin Quality Improvement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2018-07-26

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.

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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.

Conditions

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Skin Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

Hyper-Diluted Botox

Intervention Type DRUG

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

Topical anesthesia

Intervention Type DRUG

Topical anesthesia will be bilaterally applied to the mid-face region for 20 minutes

0.9% saline solution

Intervention Type OTHER

0.1ml of 0.9% saline solution will be administered to the side of the face

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.

Group Type OTHER

Hyper-Diluted Botox

Intervention Type DRUG

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

Topical anesthesia

Intervention Type DRUG

Topical anesthesia will be bilaterally applied to the mid-face region for 20 minutes

0.9% saline solution

Intervention Type OTHER

0.1ml of 0.9% saline solution will be administered to the side of the face

Interventions

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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

Intervention Type DRUG

Topical anesthesia

Topical anesthesia will be bilaterally applied to the mid-face region for 20 minutes

Intervention Type DRUG

0.9% saline solution

0.1ml of 0.9% saline solution will be administered to the side of the face

Intervention Type OTHER

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)

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes