Facial WrinklesNCT06322875
A Clinical Study to Evaluate the Efficacy and Satisfaction of RHC Serum Combined With RHC(III) Injection
A study testing Recombinant type III humanized collagen solution for injection, SkinCeuticals recombinant humanized collagen (RHC) serum and Regular face cream smear in people with Facial Wrinkles, run by DeYi Aesthetic Medical Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- Recombinant type III humanized collagen solution for injection, SkinCeuticals recombinant humanized collagen (RHC) serum and Regular face cream smear
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.);
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
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)
Read the 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)
- Conditions
- Facial Wrinkles
- Being tested
- Recombinant type III humanized collagen solution for injection, SkinCeuticals recombinant humanized collagen (RHC) serum, Regular face cream smear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant type III humanized collagen solution for injectionProcedure or surgery
Each subject will receive one injection of Recombinant type III humanized collagen solution for injection on the whole face
SkinCeuticals recombinant humanized collagen (RHC) serumOther
Subjects received SkinCeuticals recombinant humanized collagen (RHC) serum application on the test side face
Regular face cream smearOther
Subjects received Regular face cream smear application on the whole face
| Study group | Role | What they receive |
|---|---|---|
| Test Side | Experimental | Each subject will randomly formulate the face on one side as the test side Receives: 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 Receives: Procedure: Recombinant type III humanized collagen solution for injection; Other: Regular face cream smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks after injection
Secondary outcomes (8)
Investigator Global Aesthetic Improvement Scale (I-GAIS) Rates
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 5-level scale ranging from "1" (very much improved) to "5" (very much worse) to determine the degree of improvement of the treated areas.
the rates of I-GAIS was defined as the proportion of subjects with a GAIS score of 1-3.
Measured: 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
Subject Global Aesthetic Improvement Scale (S-GAIS) is a 5-level scale ranging from "1" (very much improved) to "5" (very much worse) to determine the degree of improvement of the treated areas.
the rates of S-GAIS was defined as the proportion of subjects with a GAIS score of 1-3.
Measured: 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
The investigator evaluated the improvement around the face using Atlas facial wrinkle atlas, a validated wrinkle scoring system, in which crow's feet were divided into 7 different grades, forehead wrinkles were divided into 9 grades, forehead fine lines were divided into 8 grades, and Yintang wrinkles were divided into 7 grades. A higher grade means more wrinkles.The improvement rate was defined as the proportion of subjects with at least 1 point reduction in the wrinkle rating in different regions.
Measured: 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
The Cutometer® dual will be used to assess changes in skin outcomes. Analysis will be conducted by a board-certified dermatologist at baseline and follow up. Evaluated skin properties/parameters included skin moisture content, transepidermal water loss, skin elasticity, and skin tightness. Collection of these parameters will be performed using a probe dedicated to the Cutometer®dual. The results are then used to generate a comprehensive analysis report, which includes both the quantitative measurements and qualitative assessments, along with any corresponding scores or ratings assigned to different skin attributes.
Measured: 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
VISIA® Skin Analysis system will be used to assess changes in skin outcomes. Analysis will be conducted by a board-certified dermatologist at Baseline and follow up. The VISIA® Skin Analysis system will be used to capture the images which will then be processed by the VISIA software.The software utilizes advanced algorithms to detect and measure specific skin attributes. The skin attributes/parameters evaluated will be spots, pores, wrinkles, texture (roughness and smoothness of the skin), purple patches of the dermal layer, brown patches of the dermal layer, red areas and porphyrins. These parameters are evaluated using the captured images and the specialized algorithms employed by the VISIA software. The results are then used to generate a comprehensive analysis report, which includes both the quantitative measurements and qualitative assessments, along with any corresponding scores or ratings assigned to different skin attributes.
Measured: 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.
FACE-Q Satisfaction with Outcome
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 perspective and impact of 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 outcome
Measured: 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.
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
Measured: Enrollment day, 2 weeks ±3 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
Change of the thickness and density of subjects' facial dermis
Evaluation of the thickness and density of subjects' facial dermis. Subject will be submitted to the Ultrascan UC 22 equipment.
Measured: Enrollment day, 2 weeks ±3 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DeYi Aesthetic Medical Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaolei Qin, Principal investigator, DeYi Aesthetic Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322875
- Sponsor's protocol ID
- SKCCOL002
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data obtained during a clinical trial is owned jointly by the investigator and the clinical trial facility. Under the premise of mutual consultation, the clinical trial institution or the investigator decides to publish the research results.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06322875
- Acronym / sponsor ID
- SKCCOL002
- Conditions
- Facial Wrinkles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- DeYi Aesthetic Medical ClinicUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Side | Experimental | Procedure: Recombinant type III humanized collagen solution for injection, Other: SkinCeuticals recombinant humanized collagen (RHC) serum, Other: Regular face cream smearEach subject will randomly formulate the face on one side as the test side |
| Control Side | Placebo comparator | Procedure: Recombinant type III humanized collagen solution for injection, Other: Regular face cream smearEach subject will randomly formulate the face on one side as the control side |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant type III humanized collagen solution for injectionEach subject will receive one injection of Recombinant type III humanized collagen solution for injection on the whole face | Procedure or surgery | Control Side, Test Side |
| SkinCeuticals recombinant humanized collagen (RHC) serumSubjects received SkinCeuticals recombinant humanized collagen (RHC) serum application on the test side face | Other | Test Side |
| Regular face cream smearSubjects received Regular face cream smear application on the whole face | Other | Control Side, Test Side |
Primary outcome
FACE-Q Satisfaction with skin
Time frame: 4 weeks after injection
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
8 secondary outcomes
Investigator Global Aesthetic Improvement Scale (I-GAIS) Rates
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
FACE-Q Satisfaction with Outcome
Time frame: 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.
FACE-Q Satisfaction with skin
Time frame: Enrollment day, 2 weeks ±3 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
Change of the thickness and density of subjects' facial dermis
Time frame: Enrollment day, 2 weeks ±3 days after injection, 8 weeks ±2 weeks after injection, and 12 weeks ±2 weeks after injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No. All data obtained during a clinical trial is owned jointly by the investigator and the clinical trial facility. Under the premise of mutual consultation, the clinical trial institution or the investigator decides to publish the research results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaolei Qin principal investigator
DeYi Aesthetic Medical Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant type III humanized collagen solution for injection, SkinCeuticals recombinant humanized collagen (RHC) serum and Regular face cream smear in people with Facial Wrinkles, run by DeYi Aesthetic Medical Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifan Cui (18514470815, rachelcui0909@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACE-Q Satisfaction with skin (time frame: 4 weeks after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.