Clinical Research Directory

Safety and Effectiveness of NOA HYDRATION Injectable Gel for the Improvement of Skin Quality Including Attributes Such as Skin Smoothness

Sponsor: AbbVie

Summary

Facial skin quality, including attributes such as skin smoothness, can be affected by intrinsic aging and environmental factors. The goal of this study is to evaluate the safety and effectiveness of NOA HYDRATION, an injectable gel designed for intradermal placement, in improving facial skin quality including attributes such as skin smoothness in Chinese adults. NOA HYDRATION is an investigational device being developed for improvement of facial skin quality including attributes such as skin smoothness. Participants are placed into one of two groups - a treatment group or a control group (no-treatment control). There is a 1 in 3 chance that participants will be assigned to the control group. Approximately 150 adult participants seeking improvement in skin quality including attributes such as skin smoothness will be enrolled at approximately 7 sites in China. Participants in the treatment group will receive intradermal injections of NOA HYDRATION to the facial area (excluding forehead, nose, lips, and periocular areas) on Day 1. An optional touch-up treatment may be given at Day 31. The treatment group will be followed for 12 months after the last treatment. Participants in the control group will receive no treatment for 2 months, then may receive optional treatment and will be followed for 9 months after treatment. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a clinic. The effects of the treatment will be checked by medical assessments, questionnaires, photography, and checking for side effects.

Official title: A Prospective, Multicenter, Evaluator-Blinded, Randomized, No-treatment-controlled Study to Evaluate the Safety and Effectiveness of NOA HYDRATION in the Improvement of Skin Quality Including Attributes Such as Skin Smoothness

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