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Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles

NCT06854796•Shaanxi Giant Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

Trial name: Prospective, multicentre, randomized, blind, parallel-controlled clinical trial to evaluate the efficacy and safety of recombinant collagen gel for correcting moderate to severe nasolabial wrinkles Sponsor: Shaanxi Juzi Biotechnology Co., LTD Objective: To evaluate the efficacy and safety of recombinant collagen gel prepared by Shaanxi Juzi Biotechnology Co., LTD Experimental design: A prospective, multicenter, randomized, blind, parallel controlled experimental design was adopted, and the comparison type was non-inferiority test Sample size: 244 cases Experimental group: control group =1:1 Scope of application: It is suitable for injection into facial dermis or subcutaneous tissue to correct moderate and severe nasolabial wrinkles Case selection: Inclusion criteria (1) Age 18-65 years old (including the threshold value), male and female; (2) Those who have a need to improve nasolabial wrinkles and are rated moderate or severe (corresponding to a score of 3 or 4) on the bilateral nasolabial Wrinkles Severity Rating Scale (as assessed by blind investigators); (3) Voluntarily participate in this clinical trial and sign the subject informed consent.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age range of 18-65 years old (including threshold), regardless of gender;
•2. There is a need to improve nasolabial folds, and the bilateral nasolabial folds severity rating scale (WSRS) is rated as moderate or severe (corresponding to a score of 3 or 4) by blinded researchers;
•3. Voluntarily participate in this clinical trial and sign the informed consent form for the subjects.

Exclusion Criteria

•1. Patients with acute or advanced skin diseases (vitiligo, psoriasis, eczema, etc.), obvious scars, active inflammation, infections (bacterial, fungal, viral), cancerous or precancerous lesions, or unhealed wounds in the nasolabial groove area;
•2. Those who have received permanent or semi permanent dermal filler treatment (such as hydroxyapatite calcium, polymethyl methacrylate, organosilicon, expanded polytetrafluoroethylene, etc.) at the folds of the nasolabial groove, or plan to receive filler treatment during the study period;
•3. Screening for individuals who have undergone facial plastic surgery or other cosmetic procedures at the intended injection site or lower middle part of the nasolabial fold in the previous 6 months, which may affect the WSRS rating (such as facial lifting surgery, botulinum toxin injection, etc.); Or those who plan to undergo any other facial surgery, medication, or laser treatment during the study period;
•4. Individuals who have received temporary filler injections such as cross-linked hyaluronic acid, collagen, or polylactic acid in the nasolabial groove area within the previous 12 months, or who have received non cross-linked sodium hyaluronate injections in the nasolabial groove area within the previous 6 months;
•5. Scar lumps, scar constitution, and individuals in the active phase of infectious diseases;
•6. Those who have bleeding tendency and used anticoagulants within 2 weeks (heparin, warfarin, sodium citrate, aspirin, etc.), uncontrolled diabetes (HbA1c ≥ 7.5%), malignant tumors and other serious systemic diseases, or autoimmune diseases, such as rheumatism, lupus erythematosus, or immune dysfunction;
•7. Patients with platelet count below 50 × 109/L or abnormal coagulation mechanism (such as APTT ≥ 1.5 times the upper limit of normal) during the screening period;
•8. Abnormal liver and kidney function during the screening period (AST, ALT\>1.5 times the upper limit of normal values or Cr\>1.5 times the upper limit of normal values);
•9. Individuals who have a history of allergies or allergies to local anesthetics such as pig derived materials or collagen materials, potassium dihydrogen phosphate, disodium hydrogen phosphate, or lidocaine (allergic to one or more substances);
•10. Visual impairment that affects the subject's self-evaluation;
+4 more criteria

Locations (1)

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

Beijing, China

Key Dates

Start Date

January 10, 2025

Primary Completion Date

October 1, 2025

Completion Date

December 31, 2026

Last Updated

March 3, 2025

Enrollment

244

ESTIMATED participants

Conditions

Nasolabial Fold Wrinkles

Interventions

Recombinant collagen gel

DEVICE

collagen implant agent

DEVICE

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ACTIVE_NOT_RECRUITINGNA

Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds

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Nasolabial Fold Wrinkles

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles

Inclusion Criteria

Exclusion Criteria

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds

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DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up

Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles