Evaluation of Skin Quality Improvement

NCT03097835 | Completed Phase 2 FDA Drug

• 1 other identifier: HDB101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient and Investigator Reported Outcomes

  Entire duration of the study (Day 1-Day 135)

Study Arms (2)

Group A

OTHER

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; Drug: Topical anesthesia; Other: 0.9% saline solution

Group B

OTHER

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; Drug: Topical anesthesia; Other: 0.9% saline solution

Interventions

Hyper-Diluted Botox 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

Group A; Group B

Topical anesthesia DRUG

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

Group A; Group B

0.9% saline solution OTHER

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

Group A; Group B

Eligibility Criteria

• Age: 35 Years - 55 Years
• Gender Eligibility Details: Females of reproductive age must use acceptable and reliable forms of birth control Females of reproductive age must undergo urine pregnancy testing
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Steve Yoelin M.D. Medical Associates, Inc.: lead
• Allergan: collaborator

Study Sites (1)

Steve Yoelin MD & Associates

Newport Beach, California, 92663, United States

Location

Related 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. doi: 10.1111/j.1473-2165.2006.00255.x.

  PMID: 17177750 RESULT

• Diamond A, Jankovic J. Botulinum toxin in dermatology - beyond wrinkles and sweat. J Cosmet Dermatol. 2006 Jun;5(2):169. doi: 10.1111/j.1473-2165.2006.00250.x. No abstract available.

  PMID: 17173593 RESULT

• 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. Epub 2009 Oct 3.

  PMID: 19802513 RESULT

MeSH Terms

Interventions

Anesthesia; Saline Solution

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: February 12, 2018
• Primary Completion: July 12, 2018
• Study Completion: July 26, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)