Clinical trial NCT06322875: A Clinical Study to Evaluate the Efficacy and Satisfaction of RHC Serum Combined With RHC(III) Injection
Official title: A Prospective, Single-center, Randomized, Split-face Controlled, Single-blind Evaluation, Superiority Clinical Trial to Evaluate the Efficacy and Safety of RHC(III) for Injection Combined With SkinCeuticals RHC Serum.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Facial Wrinkles
Lead sponsor: DeYi Aesthetic Medical Clinic
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 54
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of recombinant humanized collagen (type III) solution for injection combined with SkinCeuticals recombinant humanized collagen (RHC) serum Participants will be assessed by subjective questionnaire (FACE-Q Satisfaction with skin,Global Aesthetic Improvement Scale, et al) and some medical instruments (VISIA,Ultrascan UC22 et al)

Detailed description: With the growth of photoaging and age, more people have the appearance of fine lines, skin laxity, roughness. Clinical evidences shown that RHC III injection can effectively improve fine line, skin plumpness and firmness to some extent; SkinCeutials RHC serum is capable of improving skin plumpness, firmness and elasticity, and improve rough skin condition.

A Prospective, single-center, randomized, split-face controlled, single-blind evaluation, superior efficacy clinical trial to evaluate the efficacy and safety of recombinant humanized collagen (type III) solution for injection combined with SkinCeuticals recombinant humanized collagen (RHC) serum, to explore the synergetic effects of injectable integrated skincare in Chinese population.

A total of 54 subjects will be enrolled in this study, and half of the face of each subject will be randomly assigned 1:1 to the test side and the control side.

The subjects will receive one injection of recombinant type III humanized collagen solution and will be followed up for 12 weeks after injection treatment.

Experimental group: SkinCeuticals RHC cream and Regular cream (twice daily) Control group: Regular cream (twice daily)

Participants will be assessed by subjective questionnaire (FACE-Q Satisfaction with skin,Global Aesthetic Improvement Scale, et al) and some medical instruments (VISIA,Ultrascan UC22 et al)

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

Primary outcomes:
measure: FACE-Q Satisfaction with skin
timeFrame: 4 weeks after injection
Secondary outcomes:
measure: Investigator Global Aesthetic Improvement Scale (I-GAIS) Rates
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 4 weeks ±5 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
measure: Subject Global Aesthetic Improvement Scale (S-GAIS) Rates
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 4 weeks ±5 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
measure: Improvement rate assessed by Atlas
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 4 weeks ±5 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
measure: Change in Cutometer® dual Analysis Score
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 4 weeks ±5 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
measure: Change in VISIA® Skin Analysis Score
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 4 weeks ±5 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
measure: FACE-Q Satisfaction with Outcome
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 4 weeks ±5 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
measure: FACE-Q Satisfaction with skin
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
measure: Change of the thickness and density of subjects' facial dermis
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
Other outcomes:
measure: Changes from baseline in skin uniformity and spot area ratio measurements collected by VISIA's face image acquisition instrument.
timeFrame: Enrollment day, 2 weeks ±3 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
Locations:
Study officials:
affiliation: DeYi Aesthetic Medical Clinic
name: Xiaolei Qin
role: PRINCIPAL_INVESTIGATOR
References: