Facial Dryness, Facial Dullness
Conditions
Brief summary
The aim of the study is to evaluate the safety and efficacy of sodium hyaluronate 32 mg/ml in improving facial skin dryness and dullness. Subjects are randomized to the treatment group or to the control group. Only subjects in the treatment group are treated by intradermal injection.
Detailed description
This is a prospective multi-center clinical investigation. Enrolled subjects are randomized to the treatment group or to the no-treatment control group. The treatment group will receive intradermal injections of sodium hyaluronate 32 mg/ml. The improvement of facial skin dryness and dullness will be evaluated at multiple timepoints.
Interventions
DEVICESodium Hyaluronate
Sodium Hyaluronate 32 mg/ml
Sponsors
IBSA Farmaceutici Italia Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years old and ≤65 years old (based on the time of signing the ICF), gender is not restricted; 2. Skin Fitzpatrick is classified as type II-IV; 3. Subjects who are seeking temporary improvement of their dry facial skin and dull complexion. The investigator has assessed the subjects are suitable for receiving injectable treatment to improve these conditions; 4. Subjects who have agreed not to use any other medical cosmetic treatments related to the study during the study period; 5. Subjects who voluntarily sign a written informed consent form, and able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on investigator's judgement.
Exclusion criteria
1. Known allergy to hyaluronic acid or any component of this product; 2. Known history of severe allergies; 3. Known history of severe autoimmune disease; 4. Subjects with episode of herpes cutis; 5. Subjects with cicatricial diathesis; 6. Facial area has unknown injection substances; 7. Have received any permanent or semi-permanent fillers at the facial area (e.g., calcium hydroxyapatite, poly-L-lactic acid, polymethyl methacrylate, silicones, expanded polytetrafluoroethylene (ePTFE), polycaprolactone, etc.), autologous fat, face lift (including thread lifts), etc., or plan to receive any of the above treatments during the investigation; 8. Have received temporary dermal filler treatment (e.g., cross-linked hyaluronic acid, collagen) at the facial area within the 12 months prior to enrolment, or plan to receive any of the above treatments during the investigation; 9. Have received botulinum toxin injection, mesotherapy, or facial cosmetic procedures (e.g., facial liposuction, cosmetic surgery, face slimming, photo modulation therapy, intense pulsed light, radiofrequency, non-cross-linked hyaluronic acid injection (except for mesotherapy), dermabrasion, laser or chemical peels or other ablation procedures, etc.) at facial area within 6 months prior to enrolment, or plan to receive any of the above treatments during the investigation; 10. Have received sodium hyaluronate compound solution injection (mesotherapy, etc) at facial area within 3 months prior to enrolment, 11. Facial area has active or progressive skin infection (including viral, bacterial, fungal); 12. Facial area has skin granuloma; 13. Facial area has active or progressive skin diseases or with isomorphic reactions such as acute eczema, flat warts, lichen planus, psoriasis vulgaris, etc.; 14. Facial area has malignant tumors or skin tumors of unknown nature; 15. Subjects who work outdoors for a long time or need to be exposed to sunlight after surgery; 16. Patients with excessive expectations for treatment effects; 17. Subjects with coagulation dysfunction or other systemic diseases; 18. Subjects undergoing chemotherapy/radiotherapy; 19. Subjects with mental illness or emotional instability; 20. Subjects who had received any thrombolytic agents, anticoagulants or antiplatelet drugs within 2 weeks before enrolment; 21. Subjects who are pregnant or planned to become pregnant during the investigation period, or breastfeeding; 22. Subject who participated in other clinical investigation within 1 month prior to enrolment in this investigation, or currently participating in other clinical investigation; 23. The investigator considers that the subject is not suitable to participate in this clinical investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator | 12 week | Treatment effective rate (third-party blinded investigator assessment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of skin moisture | 4week, 8week, 10week, 12week, 16week, 20week | Corneometer assessment |
| GAIS-Blinded evaluator | 4week, 8week, 10week, 16week, 20week | Treatment effective rate (third-party blinded investigator assessment) |
| GAIS-Investigator | 4week, 8week, 10week, 12week, 16week, 20week | Treatment effective rate (treating investigator assessment) |
| Skin dryness improvement assessment - Investigator | 4week, 8week, 10week, 12week, 16week, 20week | Dryness improvement assessment will be performed by the treating investigator. The following scoring will be applied: -1: worse, 0= no change, 1=improvement. |
| Skin dryness improvement assessment - Subject | 4week, 8week, 10week, 12week, 16week, 20week | Dryness improvement assessment will be performed by the subect. The following scoring will be applied: -1: worse, 0= no change, 1=improvement. |
| Skin dullness improvement assessment - Investigator | 4week, 8week, 10week, 12week, 16week, 20week | Skin dullness improvement assessment will be performed by the treating investigator. The following scoring will be applied: -1: worse, 0= no change, 1=improvement. |
| Skin dulless improvement - Subject | 4week, 8week, 10week, 12week, 16week, 20week | Skin dullness improvement assessment will be performed by the subject. The following scoring will be applied: -1: worse, 0= no change, 1=improvement. |
| Subject treatment satisfaction assessment scale | 4week, 8week, 10week, 12week, 16week, 20week | For the question How do you feel satisfied with the treatment effect of the investigational product?, the answer criteria are from 1 to 5, where 1= very dissatisfied and 5= very much satisfied. |
| Red blood cell (RBC) | 0week, 12week, 32 week | — |
| White blood cell (WBC) | 0week, 12week, 32 week | — |
| Platelet count (PLT) | 0week, 12week, 32 week | — |
| Hemoglobin (HGB) | 0week, 12week, 32 week | — |
| Serum alanine aminotransferase (ALT) | 0week, 12week, 32 week | — |
| Serum aspartate aminotransferase (AST) | 0week, 12week, 32 week | — |
| Serum urea nitrogen/urea (BUN/Urea) | 0week, 12week, 32 week | — |
| Serum creatinin (Cr) | 0week, 12week, 32 week | — |
| Blood glucose (GLU) | 0week, 12week, 32 week | — |
| Urine pH | 0week, 12week, 32 week | — |
| Urine glucose | 0week, 12week, 32 week | — |
| GAIS-Subject | 4week, 8week, 10week, 12week, 16week, 20week | Treatment effective rate (subject assessment) |
| Urine specific gravity | 0week, 12week, 32 week | — |
| Urine red blood cell count | 0week, 12week, 32 week | — |
| Urine white blood cell count | 0week, 12week, 32 week | — |
| Urine nitrite | 0week, 12week, 32 week | — |
| Prothrombin time (PT) | 0week | — |
| Activated partial thromboplastin time (APTT) | 0week | — |
| Thrombin time (TT) | 0week | — |
| Fibrinogen (FIB) | 0week | — |
| Blood pressure (mmHg) | 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week | Systolic blood pressure and diastolic blood pressure will be measured |
| Temperature (°C) | 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week | — |
| Respiration rate | 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week | Times/min |
| Heart rate | 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week | Beats/min |
| Incidence rate of adverse events (AEs) | 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week | Incidence rate (%) and number of adverse events (AEs) |
| Incidence rate of serious adverse events (SAEs) | 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week | Incidence rate (%) and number of serious adverse events (SAEs) |
| Incidence rate of adverse device effects (ADE) | 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week | Incidence rate (%) and number of adverse device effects (ADE) |
| Incidence rate of serious adverse device effects (SADE) | 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week | Incidence rate (%) and number of serious adverse device effects (SADE) |
| Incidence rate of injection site reactions | 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week | Incidence rate (%) and number of injection site reactions |
| Incidence rate of device deficiencies | 0week, 4week, 8week | Incidence rate (%) and number of of device deficiencies |
| Urine protein | 0week, 12week, 32 week | — |
Countries
China
Contacts
Primary ContactYan Wu, Professor
Outcome results
None listed