CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
onabotulinumtoxinA +1 moredrug
Likely dose
Not stated in 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/NCT02907268
NCT02907268Phase 2Completed
CompareCT.gov

A Single Blind, Split-Face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging

ICLS Dermatology & Plastic Surgery·interventional·Posted Sep 20, 2016·Updated Oct 13, 2017

In Brief

A Phase 2 clinical trial evaluating onabotulinumtoxinA and abobotulinumtoxinA for Facial Rhytids. Completed, enrolled 10 participants.

Detailed Summary

A 16-week single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal BTXA injections at week 0 and intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Rhytids
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 20, 2016
Enrollment StartSep 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.8 years ago

Interventions

onabotulinumtoxinAdrug

OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.

abobotulinumtoxinAdrug

AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.