Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)NCT07897773
Recombinant Collagen Freeze-Dried Fibre for Upper Facial Wrinkles
A study testing Recombinant Collagen Freeze-Dried Fibers and Collagen Implant in people with Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines), run by Shaanxi Giant Biotechnology Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial was to learn whether a collagen filler improved facial wrinkles. The study product was injectable recombinant collagen freeze-dried fibers. Recombinant collagen is collagen made using genetic engineering. Participants were adults aged 18 to 65 with upper facial wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)
- What is being tested?
- Recombinant Collagen Freeze-Dried Fibers and Collagen Implant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2022to 25 Aug 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years, inclusive, of any sex.
- Seeking correction of upper facial wrinkles, including glabellar lines, forehead lines, or crow's feet.
- Wrinkle severity grade of 2 or higher on a five-point scale.
- Willing to participate in the trial and provide written informed consent.
Who cannot join
- Allergy to local anesthetics, such as lidocaine, or collagen.
- History of keloids or hypertrophic (raised) scars.
- Acute or worsening skin disease at the injection site. Examples include active acne, acute or subacute eczema, contact dermatitis, psoriasis, and vitiligo.
- Open wounds or active skin infections at the injection site.
- Clinically significant illness within 3 months before the study began. Examples include significant abnormal laboratory results, heart attack, stroke, cancer, connective tissue disease, systemic infection, and uncontrolled diabetes.
- Platelet count below 50 × 10^9/L or abnormal blood clotting at screening. Abnormal clotting means activated partial thromboplastin time (APTT) above 1.5 times the upper limit of normal.
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- Use of immunosuppressants or corticosteroids within 2 months before the study, or planned use during the trial.
- Use of tretinoin or isotretinoin within 1 month before the study, or planned use during the trial.
- Filler injections, surgery, or other treatments on the upper face outside the study protocol within 6 months before the study, or planned during the trial. Examples include facelift surgery, botulinum toxin injections, laser treatment, and plastic surgery.
- Unable to receive porcine-derived medical products, including the control product, for religious, ethnic, or other reasons.
- Pregnant, breastfeeding, or planning to become pregnant during the trial.
- Participation in another drug or medical device trial within 3 months before screening.
- Considered unsuitable by the researchers because of difficulty following trial requirements, impaired perception, or other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
The Seventh Medical Center of the Chinese People's Liberation Army General Hospital
Beijing
About this study
Official title: Prospective, Multicenter, Randomized, Blinded, Parallel-Controlled, Non-Inferiority Clinical Trial of Recombinant Collagen Freeze-Dried Fibre for Facial Filling to Correct Upper Facial Wrinkles
The goal of this clinical trial was to learn whether a collagen filler improved facial wrinkles. The study product was injectable recombinant collagen freeze-dried fibers. Recombinant collagen is collagen made using genetic engineering. Participants were adults aged 18 to 65 with upper facial wrinkles. These included forehead lines, lines between the eyebrows, and lines beside the eyes.
The trial also studied the product's safety. The main questions it aimed to answer were:
Read more
- How many participants had fewer wrinkles 90 days after their final treatment?
- What side effects or other medical problems occurred during treatment and follow-up? Researchers compared the study product with Sunmax Collagen Implant I, another collagen filler. They compared how many participants improved in each group. Improvement meant wrinkles became at least one level less severe in every treated area. Researchers used a five-level scale to rate wrinkle severity.
The comparison allowed a small difference in improvement rates between the groups. Researchers set this limit before the trial began. They tested whether the study product stayed within that limit compared with the other filler.
Participants were asked to:
- Receive one of the two products, with their group chosen by chance.
- Receive three injection treatments, about 30 days apart.
- Record reactions in a diary for 14 days after each treatment.
- Attend follow-up visits about 30, 90, and 180 days after their final treatment.
- Have facial photographs taken for wrinkle assessments.
- Rate changes in their appearance and report any medical problems.
- Being tested
- Recombinant Collagen Freeze-Dried Fibers, Collagen Implant
- Keywords
- Forehead Lines, Glabellar Lines, Crow's feet, Recombinant collagen, Free-dried fibers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Collagen Freeze-Dried FibersDevice
Recombinant collagen freeze-dried fibers manufactured by Shaanxi Giant Biotechnology Co., Ltd. Participants received injections to treat upper facial wrinkles. They received three treatments, 30 days apart.
Collagen ImplantDevice
Also called Sunmax Collagen Implant I
Sunmax Collagen Implant I manufactured by Sunmax Biotechnology Co., Ltd. Participants received injections to treat upper facial wrinkles. They received three treatments, 30 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Collagen Freeze-Dried Fibers | Experimental | Participants received recombinant collagen freeze-dried fiber injections to treat upper facial wrinkles. They received three treatments, 30 days apart. Receives: Device: Recombinant Collagen Freeze-Dried Fibers |
| Sunmax Collagen Implant I | Active comparator | Participants received Sunmax Collagen Implant I injections to treat upper facial wrinkles. They received three treatments, 30 days apart. Receives: Device: Collagen Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Improved Upper Facial Wrinkles
An independent panel assessed standardized facial photographs without knowing participants' treatment groups. Wrinkle severity was rated using a five-point scale based on the Merz Aesthetics Scales. Scores ranged from 0 (none) to 4 (extremely severe). Higher scores indicated more severe wrinkles. Responders had at least a one-grade improvement from baseline at every treated site. For participants with multiple treated sites, the least improved site determined the response. When both sides had crow's feet treated, the less improved side determined the response. The outcome was the percentage of participants in each group who met this response definition.
Measured: Baseline and 90 days (±7 days) after the final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start4 Aug 2022
- Primary completion11 Jun 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaanxi Giant Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897773
- Sponsor's protocol ID
- MSPR-CZJYDB-202202-01
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Blinded, Parallel-Controlled, Non-Inferiority Clinical Trial of Recombinant Collagen Freeze-Dried Fibre for Facial Filling to Correct Upper Facial Wrinkles
- ClinicalTrials.gov ID
- NCT07897773
- Acronym / sponsor ID
- MSPR-CZJYDB-202202-01
- Keywords
- Forehead Lines, Glabellar Lines, Crow's feet, Recombinant collagen, Free-dried fibers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Shaanxi Giant Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 11 Jun 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 27 Oct 2026 (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.
The goal of this clinical trial was to learn whether a collagen filler improved facial wrinkles. The study product was injectable recombinant collagen freeze-dried fibers. Recombinant collagen is collagen made using genetic engineering. Participants were adults aged 18 to 65 with upper facial wrinkles. These included forehead lines, lines between the eyebrows, and lines beside the eyes.
The trial also studied the product's safety. The main questions it aimed to answer were:
- How many participants had fewer wrinkles 90 days after their final treatment?
- What side effects or other medical problems occurred during treatment and follow-up? Researchers compared the study product with Sunmax Collagen Implant I, another collagen filler. They compared how many participants improved in each group. Improvement meant wrinkles became at least one level less severe in every treated area. Researchers used a five-level scale to rate wrinkle severity.
The comparison allowed a small difference in improvement rates between the groups. Researchers set this limit before the trial began. They tested whether the study product stayed within that limit compared with the other filler.
Participants were asked to:
- Receive one of the two products, with their group chosen by chance.
- Receive three injection treatments, about 30 days apart.
- Record reactions in a diary for 14 days after each treatment.
- Attend follow-up visits about 30, 90, and 180 days after their final treatment.
- Have facial photographs taken for wrinkle assessments.
- Rate changes in their appearance and report any medical problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Collagen Freeze-Dried Fibers | Experimental | Device: Recombinant Collagen Freeze-Dried FibersParticipants received recombinant collagen freeze-dried fiber injections to treat upper facial wrinkles. They received three treatments, 30 days apart. |
| Sunmax Collagen Implant I | Active comparator | Device: Collagen ImplantParticipants received Sunmax Collagen Implant I injections to treat upper facial wrinkles. They received three treatments, 30 days apart. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 65 years, inclusive, of any sex.
- Seeking correction of upper facial wrinkles, including glabellar lines, forehead lines, or crow's feet.
- Wrinkle severity grade of 2 or higher on a five-point scale.
- Willing to participate in the trial and provide written informed consent.
Key exclusion criteria (13 listed)
- Allergy to local anesthetics, such as lidocaine, or collagen.
- History of keloids or hypertrophic (raised) scars.
- Acute or worsening skin disease at the injection site. Examples include active acne, acute or subacute eczema, contact dermatitis, psoriasis, and vitiligo.
- Open wounds or active skin infections at the injection site.
- Clinically significant illness within 3 months before the study began. Examples include significant abnormal laboratory results, heart attack, stroke, cancer, connective tissue disease, systemic infection, and uncontrolled diabetes.
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 Collagen Freeze-Dried FibersRecombinant collagen freeze-dried fibers manufactured by Shaanxi Giant Biotechnology Co., Ltd. Participants received injections to treat upper facial wrinkles. They received three treatments, 30 days apart. | Device | Recombinant Collagen Freeze-Dried Fibers |
| Collagen ImplantAlso: Sunmax Collagen Implant ISunmax Collagen Implant I manufactured by Sunmax Biotechnology Co., Ltd. Participants received injections to treat upper facial wrinkles. They received three treatments, 30 days apart. | Device | Sunmax Collagen Implant I |
Primary outcome
Percentage of Participants With Improved Upper Facial Wrinkles
Time frame: Baseline and 90 days (±7 days) after the final treatment.
An independent panel assessed standardized facial photographs without knowing participants' treatment groups. Wrinkle severity was rated using a five-point scale based on the Merz Aesthetics Scales. Scores ranged from 0 (none) to 4 (extremely severe). Higher scores indicated more severe wrinkles. Responders had at least a one-grade improvement from baseline at every treated site. For participants with multiple treated sites, the least improved site determined the response. When both sides had crow's feet treated, the less improved side determined the response. The outcome was the percentage of participants in each group who met this response definition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Collagen Freeze-Dried Fibers and Collagen Implant in people with Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines), run by Shaanxi Giant Biotechnology Co., Ltd at 1 site in China.
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 13 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: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Improved Upper Facial Wrinkles (time frame: Baseline and 90 days (±7 days) after the final treatment.). 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 27 Oct 2026.