A Clinical Study to Evaluate the Efficacy and Satisfaction of RHC Serum Combined With RHC(III) Injection

Launched by DEYI AESTHETIC MEDICAL CLINIC · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for facial wrinkles using a combination of a special serum and an injection of collagen. Collagen is a protein that helps keep our skin smooth and youthful. The goal of the study is to see how effective this treatment is and how satisfied participants are with the results. Women aged 30 to 55 who have rough, dry skin with noticeable fine lines may be eligible to join the trial. To participate, they will need to sign a consent form and agree to follow the study's requirements.

Participants in the trial can expect to answer questions about their skin satisfaction and undergo some assessments to measure changes in their skin's appearance. It’s important to note that certain conditions, such as active skin diseases or recent cosmetic treatments, may disqualify potential participants. The trial is not yet recruiting, but it aims to provide valuable information about this new treatment for improving the look of facial wrinkles.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women between the ages of 30 and 55;
• • According to the researchers' judgment, the subjects' facial skin is rough, dry and has obvious fine lines, and the Glogau photoaging rating is II to IV, which can be improved by treatment;
• • Subjects voluntarily sign informed consent and agree to complete the follow-up prescribed by the trial.
• • Note: All the above items are eligible for inclusion.
• Exclusion Criteria:
• • The subject has facial scars or skin diseases that may affect the judgment of the treatment effect, is in the stage of allergic attack, or has active infections (such as inflammatory acne, herpes simplex, etc.), and/or unhealed wounds, and is in the stage of progressive skin diseases such as vitiligo, psoriasis, etc.;
• * had received or planned to have the following surgery or treatment prior to screening that affected the trial during the study period:
• • 1. Before screening or during the study period, it is planned to perform comprehensive surgical treatment for facial wrinkles, such as silicone, autologous fat transplantation, facial lift surgery, catch-line lifting, permanent dermal fillers (such as polymethyl methacrylate);
• • 2. Treatment with semi-permanent dermal fillers (e.g., L-lactic acid, hydroxyapatite, polycaprolactones, etc.) is planned for 18 months before screening or during the study period;
• • 3. Treatment with biodegradable dermal fillers (such as sodium hyaluronate gel or collagen) planned for 12 months prior to screening or during the study period;
• • 4. Screening 6 months before or during the study period is planned in the overall Department: Botulinum toxin, plastic therapy, energy equipment other than light conditioning therapy and intense pulse light (such as laser, radio frequency, ultrasound, etc.), skin grinding, chemical exfoliation of medium depth or greater depth or other exfoliative treatment (such as trichloroacetic acid, carbonic acid, 10% or more concentration of fruit acid or 2% or more concentration of salicylic acid, etc.);
• • 5. Light conditioning therapy, intense pulsed light, shallow exfoliation, or other exfoliative therapy (e.g., hydroxy acid at concentrations below 10% or salicylic acid at concentrations below 2%, etc.) are planned for 3 months prior to screening or during the study period;
• • a history of multiple severe or hereditary allergies to any part of the body, who plan to undergo desensitization during the study period, or who are allergic to the ingredients of the drugs or devices used in the experimental treatment (hyaluronic acid, streptococcal protein, lidocaine or other amide anesthetics, etc.);
• • the subject has a history of abnormal coagulation function, or has used or plans to use anticoagulation, antiplatelet, or thrombolytic therapy (e.g., warfarin, aspirin, etc.) within 14 days prior to screening;
• • pregnancy or breastfeeding, planned pregnancy during the test, or positive pregnancy test results during the screening period;
• • The subject has a history of serious diseases of major organs or active autoimmune diseases;
• • Those with hypertrophic scars or cicatricial constitution;
• • Participants who have participated in other clinical trials within 30 days prior to the screening period;
• • The subject is judged by the investigator to have other systemic diseases that are not suitable for participation in the study;
• • Subjects who are unable to communicate or do not follow instructions;
• • Other conditions that the investigator considers inappropriate to participate in this experiment.
• • Note: All the above items are "no" to be selected