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
Verified date | February 2019 |
Source | Steve Yoelin M.D. Medical Associates, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Steve Yoelin MD & Associates | Newport Beach | California |
Lead Sponsor | Collaborator |
---|---|
Steve Yoelin M.D. Medical Associates, Inc. | Allergan |
United States,
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
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) |
Status | Clinical Trial | Phase | |
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