Evaluation of Skin Quality Improvement

Skin Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097835
• Other study ID #: HDB101
• Status: Completed
• Phase: Phase 2
• Start date: February 12, 2018
• Est. completion date: July 26, 2018

Study information

• Verified date: February 2019
• Source: Steve Yoelin M.D. Medical Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 26, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Skin Quality

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Steve Yoelin MD & Associates	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Steve Yoelin M.D. Medical Associates, Inc.	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

Diamond A, Jankovic J. Botulinum toxin in dermatology - beyond wrinkles and sweat. J Cosmet Dermatol. 2006 Jun;5(2):169. — View Citation

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)