A prospective, multicenter, randomized, non-treatment-controlled, evaluator-blinded, superiority clinical trial evaluating the efficacy and safety of the injectable sodium hyaluronate complex solution in improving the smoothness of the cheeks

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Intervention group:The injection will be performed using equipment on the cheek area. The injection will be carried out by the injection researcher using the experimental equipment on the research participants. This trial will perform a maximum of 3 injections on the participants' faces, with each injection spaced 1 month apart. The first two injections will be routine injections, and the third injection will be an optional supplementary injection. If the researcher assesses that the best aesthetic improvement has not been achieved, the third optional supplementary injection can be conducted with the consent of the research participants. After the trial group participants complete the injections, follow‐up visits will be conducted 1 month, 3 months, and 6 months after the last injection. The injection level is the dermal layer. The maximum single dose for a single injection on one side of the face is 2 mL, and the maximum total dose for a single injection on both cheeks is 4 mL.;Control group:Participants in the control group did not receive treatment and were followed up at 1, 3, and 6 months after randomization.; CONDITION: Facial smoothness PRIMARY OUTCOME: The blind reviewers' ratings of the ASRS scale; SECONDARY OUTCOME: The blind reviewers' scoring of the AFLS scale;The on‐site evaluation researchers' scoring of the ASRS scale;The on‐site evaluation researchers' scoring of the AFLS scale;The scores given by the research participants to the GAIS scale;Evaluation of skin moisture content changes;Post‐visual Analogue Scale (VAS) pain score;Satisfaction evaluation; INCLUSION CRITERIA: 1. Age range: 18 ‐ 65 years old (based on the date of signing the informed consent form, inclusive of the boundary value), gender not restricted; 2. Fitzpatrick skin type II ‐ IV; 3. According to the assessment by the blinded researchers, the Allergan Skin Roughness Scale (ASRS) rating for the roughness of both cheeks is level 2 or 3, and there is a need for improvement in cheek roughness; 4. The research participants voluntarily participate in this trial and sign the informed consent form.
Epistemonikos ID: 86c4121f12e6e8f0ad184c700a530ce705be6aca
First added on: Sep 12, 2026