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Skin QualityPhase 2NCT03097835

Evaluation of Skin Quality Improvement

A Phase 2 study testing Hyper-Diluted Botox, Topical anesthesia and 0.9% saline solution in people with Skin Quality, run by Steve Yoelin M.D. Medical Associates, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Skin Quality
What is being tested?
Hyper-Diluted Botox, Topical anesthesia and 0.9% saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
12 Feb 2018to 26 Jul 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Steve Yoelin MD & Associates

    Newport Beach, California, 92663

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Skin Quality
Being tested
Hyper-Diluted Botox, Topical anesthesia, 0.9% saline solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyper-Diluted BotoxDrug

    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 anesthesiaDrug

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

  • 0.9% saline solutionOther

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

Study groups in NCT03097835
Study groupRoleWhat they receive
Group AOtherGroup A will be treated with Hyper-Diluted Botox on day 1 and on day 30 they will be treated with 0.9% saline solution.
Receives: Drug: Hyper-Diluted Botox; Drug: Topical anesthesia; Other: 0.9% saline solution
Group BOtherGroup B will be treated with 0.9% saline solution on day 1 and on day 30 they will be treated with Hyper-Diluted Botox.
Receives: Drug: Hyper-Diluted Botox; Drug: Topical anesthesia; Other: 0.9% saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2017
  2. Study start12 Feb 2018
  3. Primary completion12 Jul 2018
  4. Study completion26 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03097835
Sponsor's protocol ID
HDB101
Status last verified
Feb 2019
First submitted
27 Mar 2017
Last updated
22 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared through the form of either a published paper or poster presentation.

Publications

  • 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.

    PubMed 17177750

  • 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.

    PubMed 17173593

  • 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.

    PubMed 19802513

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyper-Diluted Botox, Topical anesthesia and 0.9% saline solution in people with Skin Quality, run by Steve Yoelin M.D. Medical Associates, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Improvement in Skin Quality (time frame: Entire duration of the study (Day 1-Day 135)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03097835, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.

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