CompletedNot Applicable

Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

Germany, Poland132 participantsStarted 2020-10-27

Plain-language summary

Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Group1: Lip volume deficit with ROSSI score between 1.5 and 3 on at least the upper lip, or on both the upper and the lower lips with up to 1 point difference in ROSSI score between upper and lower lips;
✓. Group 2: Moderate to severe nasolabial folds (NLFs) with WSRS scale score 3 or 4 for each side of the face;
✓. Group 3: Mild to significant volume deficit at the cheeks level with MFVDS score 2 to 4 at each side, with up to 1 point difference in MFVDS scale score between the two sides.

What they're measuring

Responder Rate

Timeframe: Month 3 for Group 1, Month 6 for Groups 2 and 3

Trial details

NCT IDNCT04971876

SponsorHallura Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-11

View on ClinicalTrials.gov More Lips Enhancement trials