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NCT07897773

Recombinant Collagen Freeze-Dried Fibre for Upper Facial Wrinkles

Sponsor: Shaanxi Giant Biotechnology Co., Ltd

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2022-08-04

Completion Date

2023-08-25

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)

Interventions

DEVICE

Recombinant Collagen Freeze-Dried Fibers

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.

DEVICE

Collagen Implant

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.

Inclusion Criteria: 1. Adults aged 18 to 65 years, inclusive, of any sex. 2. Seeking correction of upper facial wrinkles, including glabellar lines, forehead lines, or crow's feet. 3. Wrinkle severity grade of 2 or higher on a five-point scale. 4. Willing to participate in the trial and provide written informed consent. Exclusion Criteria: 1. Allergy to local anesthetics, such as lidocaine, or collagen. 2. History of keloids or hypertrophic (raised) scars. 3. Acute or worsening skin disease at the injection site. Examples include active acne, acute or subacute eczema, contact dermatitis, psoriasis, and vitiligo. 4. Open wounds or active skin infections at the injection site. 5. 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. 6. 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. 7. Use of immunosuppressants or corticosteroids within 2 months before the study, or planned use during the trial. 8. Use of tretinoin or isotretinoin within 1 month before the study, or planned use during the trial. 9. 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. 10. Unable to receive porcine-derived medical products, including the control product, for religious, ethnic, or other reasons. 11. Pregnant, breastfeeding, or planning to become pregnant during the trial. 12. Participation in another drug or medical device trial within 3 months before screening. 13. Considered unsuitable by the researchers because of difficulty following trial requirements, impaired perception, or other reasons.

Locations (1)

The Seventh Medical Center of the Chinese People's Liberation Army General Hospital

Beijing, China