CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
Saypha® FILLER Lidocaine (HQ) +1 morecombination
Likely dose
Saypha® FILLER Lidocaine (HQ) 2 mLfrom 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/NCT04917588
NCT04917588N/ACompleted

A Prospective, Open-label, Multicentre, Randomized Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation

Croma-Pharma GmbH·interventional·Posted Jun 8, 2021·Updated Mar 14, 2025

In Brief

A clinical study evaluating Saypha® FILLER Lidocaine (HQ) and Saypha® FILLER Lidocaine (C1) for Abnormal Lip. Completed, enrolled 114 participants across 3 sites.

Detailed Summary

This is a prospective, open-label, multicentre, randomized study conducted to evaluate the effectiveness, safety and long-term safety of Saypha® FILLER Lidocaine for lip augmentation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbnormal Lip
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 8, 2021
Enrollment StartJul 28, 2020
Primary CompletionDec 14, 2020
Study CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.1 years ago

Interventions

Saypha® FILLER Lidocaine (HQ)combination

Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.

Saypha® FILLER Lidocaine (C1)combination

Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.