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Trial record 2 of 4 for:    ALVINA

Evaluation of Skin Quality Improvement

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Steve Yoelin M.D. Medical Associates, Inc.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Steve Yoelin M.D. Medical Associates, Inc.
ClinicalTrials.gov Identifier:
NCT03097835
First received: March 27, 2017
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Skin Quality
Drug: Hyper-Diluted Botox
Drug: Topical anesthesia
Other: 0.9% saline solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
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.
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Steve Yoelin M.D. Medical Associates, Inc.:

Primary Outcome Measures:
  • Percent Improvement in Skin Quality [ Time Frame: Entire duration of the study (Day 1-Day 135) ]
    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).


Secondary Outcome Measures:
  • Patient and Investigator Reported Outcomes [ Time Frame: Entire duration of the study (Day 1-Day 135) ]
    An objective observer as well as the patient will evaluate if there is an improvement in skin quality throughout the course of the study.


Estimated Enrollment: 15
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
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
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
Drug: 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
Group B
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
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
Drug: 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females of reproductive age must use acceptable and reliable forms of birth control Females of reproductive age must undergo urine pregnancy testing
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03097835

Contacts
Contact: Steve G Yoelin, MD (714)973-0330 steveyoelinmd@yahoo.com
Contact: Alvina P Le (714)973-0330

Locations
United States, California
Steve Yoelin MD & Associates Recruiting
Newport Beach, California, United States, 92663
Contact: Steve G Yoelin, MD    (714)973-0330    steveyoelinmd@yahoo.com   
Contact: Alvina P Le, Bachelor of Sciences    (714)973-0330    steveyoelinmd@yahoo.com   
Sponsors and Collaborators
Steve Yoelin M.D. Medical Associates, Inc.
Allergan
  More Information

Publications:
Responsible Party: Steve Yoelin M.D. Medical Associates, Inc.
ClinicalTrials.gov Identifier: NCT03097835     History of Changes
Other Study ID Numbers: HDB101
Study First Received: March 27, 2017
Last Updated: April 25, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: IPD will be shared through the form of either a published paper or poster presentation.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anesthetics
Pharmaceutical Solutions
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
Central Nervous System Depressants
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2017