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Evaluation of Skin Quality Improvement

NCT03097835 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-02-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Steve Yoelin M.D. Medical Associates, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2018-07-12
Completion
2018-07-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03097835 on ClinicalTrials.gov