Clinical trials of sodium hyaluronate complex solution have a set of draft guidelines issued by the China Centre for Medical Device Evaluation (CMDE) on May 17, 2023. During the end of 2022 and the beginning of 2023, clinical evaluation of sodium hyaluronate compound solution products was conducted, leading to the drafting of the current document. The CMDE is currently solicitating public comments on the draft document until the public consultation period ends on June 15, 2023.
Scope of application
The draft guidelines apply to sodium hyaluronate compound solutions primarily composed of sodium hyaluronate, and may include additional ingredients such as amino acids, vitamins, and buffer salts. The intended use of these solutions is to temporarily improve dry skin and dull complexion in adults. It is important to note that this guideline does not apply to products containing other functional ingredients or pharmaceutical ingredients like tranexamic acid.
Key Highlights
- Clinical Trial Design:
- Emphasize a prospective, randomized, controlled, and blinded trial design.
- Implement appropriate control methods to ensure baseline consistency and minimize subjective biases.
- Control Group Selection:
- Due to the absence of comparable products, opt for a superiority design without treatment control.
- Provide a well-founded rationale for determining the superiority threshold based on clinical benefits.
- Entry Criteria:
- Establish clear inclusion/exclusion criteria aligned with the product’s intended use.
- Consistently apply inclusion/exclusion criteria for both test and control groups.
- Consider factors such as allergies, skin infections, and relevant medical conditions.
- Evaluation Indices:
- Primary effectiveness evaluation: Assess global aesthetic effect (GAIS) and temporary improvement in dry skin and dull complexion.
- Secondary effectiveness evaluation: Consider skin dryness, skin tone improvement, patient satisfaction, and other relevant measures.
- Safety evaluation: Monitor adverse events, vital signs, and conduct laboratory tests.
- Clinical Trial Sample Size:
- Recommended sample size of no less than 400 cases (200 per group) to evaluate safety and efficacy.
- Account for potential dropout rates and shedding/lost visits in sample size calculations.
- Duration of Clinical Follow-up:
- Include appropriate observation time points to assess the expected duration of product effectiveness and safety.
- Typically, follow-up intervals comprise pre-injection, immediate post-injection, 1 week, 2 weeks, 4 weeks, and long-term safety assessments.
- Statistical Analysis:
- Utilize a full analysis set (FAS) and conduct an equilibrium analysis of baseline variables.
- Test pre-established hypotheses for primary effectiveness indicators in the FAS and per-protocol sets.
- Report all adverse events, including occurrence time, details, severity, and their relationship to the product.
- Provide clarity on measures taken, duration, and final outcomes.
How to submit comments
Comments from the industry can be submitted using the feedback form to the following email addresses: liulu@cmde.org.cn before June 15, 2023. The email subject title and name of the file attachment should be addressed as “Technical Review Points for Clinical Trials of Sodium Hyaluronate Complex Solution (Draft for Comments) feedback+ company name”. For any queries to ask the CMDE in specific, you may contact Lu Liu at 010-86452501 or Hong Qiu at 010-8645250.
Further information
To access the full draft guidelines and the feedback form, visit the provided link.
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