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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03097835
Other study ID # HDB101
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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