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

NCT06322875 | Not Yet Recruiting

• 1 other identifier: SKCCOL002
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Facial Wrinkles

Outcome Measures

Primary Outcomes (1)

• FACE-Q Satisfaction with skin

  FACE-Q is a recently developed and validated patient reported outcome measure (PROM) tool that allows clinicians to assess patient perspectives after medical aesthetic treatment in the face.The PROM is used to assess the satisfaction skin care as well as its treatment on the patient's quality of life (QoL). The FACE-Q utilizes five scales to measure the psychometric, QoL, patient experience, and cosmetic outcomes. Raw scores are transformed to a 0-100 scale with a higher score indicating a better satisfaction

  4 weeks after injection

Secondary Outcomes (8)

• Investigator Global Aesthetic Improvement Scale (I-GAIS) Rates

  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.

• Subject Global Aesthetic Improvement Scale (S-GAIS) Rates

  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.

• Improvement rate assessed by Atlas

  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.

• Change in Cutometer® dual Analysis Score

  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.

• Change in VISIA® Skin Analysis Score

  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.

Other Outcomes (1)

• Changes from baseline in skin uniformity and spot area ratio measurements collected by VISIA's face image acquisition instrument.

  Enrollment day, 2 weeks ±3 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.

Study Arms (2)

Test Side

EXPERIMENTAL

Each subject will randomly formulate the face on one side as the test side

Procedure: Recombinant type III humanized collagen solution for injection; Other: SkinCeuticals recombinant humanized collagen (RHC) serum; Other: Regular face cream smear

Control Side

PLACEBO COMPARATOR

Each subject will randomly formulate the face on one side as the control side

Procedure: Recombinant type III humanized collagen solution for injection; Other: Regular face cream smear

Interventions

Recombinant type III humanized collagen solution for injection PROCEDURE

Each subject will receive one injection of Recombinant type III humanized collagen solution for injection on the whole face

Control Side; Test Side

SkinCeuticals recombinant humanized collagen (RHC) serum OTHER

Subjects received SkinCeuticals recombinant humanized collagen (RHC) serum application on the test side face

Test Side

Regular face cream smear OTHER

Subjects received Regular face cream smear application on the whole face

Control Side; Test Side

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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);
• 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;
• Treatment with biodegradable dermal fillers (such as sodium hyaluronate gel or collagen) planned for 12 months prior to screening or during the study period;
• 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.);
• 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;

Sponsors & Collaborators

• DeYi Aesthetic Medical Clinic: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Xiaolei Qin

  DeYi Aesthetic Medical Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Cui

CONTACT

18514470815; rachelcui0909@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 21, 2024
• Study Start: March 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share