Evaluation of Skin Quality Improvement

Steve Yoelin M.D. Medical Associates, Inc.

Status and phase: Completed; Phase 2

Conditions: Skin Quality

Treatments: Other: 0.9% saline solution; Drug: Hyper-Diluted Botox; Drug: Topical anesthesia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03097835

HDB101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups

Group A

Other group

Description:

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.

Treatment:

Drug: Hyper-Diluted Botox

Other: 0.9% saline solution

Drug: Topical anesthesia

Group B

Other group

Description:

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.

Treatment:

Drug: Hyper-Diluted Botox

Other: 0.9% saline solution

Drug: Topical anesthesia