CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Hyper-Diluted Botox +2 moredrug
Likely dose
Hyper-Diluted Botox 0.1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03097835
NCT03097835Phase 2Completed
CompareCT.gov

Evaluation of Skin Quality Improvement When Hyper-Diluted OnabotulinumtoxinA (Botox®, Botox® Cosmetic /BTXa/) is Injected Into The Superficial Dermis of the Mid-Face

Steve Yoelin M.D. Medical Associates, Inc.·interventional·Posted Mar 31, 2017·Updated Feb 22, 2019

In Brief

A Phase 2 clinical trial evaluating Hyper-Diluted Botox, Topical anesthesia, and 1 other intervention for Skin Quality. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Quality
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 31, 2017
Enrollment StartFeb 12, 2018
Primary CompletionJul 12, 2018
Study CompletionJul 26, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.3 years ago

Interventions

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