Minimally invasive cosmetic treatments have surged in popularity, with a significant increase in procedures like facial injections. According to the American Society of Plastic Surgeons, over 6 million minimally invasive cosmetic procedures were performed in 2023.
Among these minimally invasive procedures, skin boosters are a popular non-surgical option for individuals seeking facial enhancements. Rejuran, a relatively new player in the cosmetic treatment market, is known for its skin rejuvenation properties. Derived from salmon DNA, Rejuran aims to improve skin texture, elasticity, and overall appearance by promoting collagen production and skin healing.
In this article, we will explore whether Rejuran has received FDA approval, its benefits, and what you should consider before opting for this treatment.
Key Takeaways
- The US Food and Drug Administration (FDA) mandates adherence to high-quality manufacturing standards, and its approval signifies that manufacturers consistently meet these criteria.
- However, Rejuran Healer has not yet undergone the FDA’s rigorous evaluation to ensure its safety and effectiveness.
- This lack of approval may prompt medical professionals to recommend alternative skin boosters for their patients.
- The Rejuran manufacturer conducted several clinical trials to assess the skin booster’s effectiveness for full-face rejuvenation, under-eye area treatment, and scar reduction.
- Obtaining US FDA approval would enhance medical professionals’ trust in Rejuran’s effectiveness in addressing facial aesthetic issues.
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Understanding the Significance of FDA Approval
The US Food and Drug Administration (FDA) has evaluated and approved numerous medications with proven safety and efficacy. However, Rejuran Healer has not yet undergone the FDA’s rigorous evaluation to ensure its safety and effectiveness.
Before approval, the Rejuran manufacturer must conduct extensive clinical trials, research, and analysis to substantiate its claims of significant benefits and minimal risks to patients. The FDA’s review process safeguards public health by ensuring that only safe and effective treatments reach the market.
Additionally, the FDA mandates adherence to high-quality manufacturing standards. Approval signifies that manufacturers consistently meet these criteria. Compliance involves regular inspections and quality control measures, ensuring Rejuran Healer’s integrity and reliability.
Clinical Trials and Studies for Rejuran
Rejuran’s manufacturer conducted several clinical trials to assess the skin booster’s effectiveness for full-face rejuvenation, under-eye area treatment, and scar reduction. These trials ensured comprehensive data collection and analysis of Rejuran Healer’s polynucleotide-based injectable, evaluating its efficacy and safety.
The clinical trial for full-face rejuvenation involved administering four Rejuran treatments at two-week intervals. The results indicated significant improvements in pore size and skin thickness for participants in their 30s, while skin tone, melanin levels, wrinkles, and sagging showed noticeable enhancement in participants in their 40s. Additionally, other benefits include the following:
- Improved Hydration
- Reduced Wrinkles and Sagging Skin
- Reduced Pigmentation
An under-eye rejuvenation clinical trial involved administering Rejuran treatments every two weeks, totaling three sessions over 12 weeks. The application of Rejuran salmon DNA significantly reduced or even eliminated crow’s feet and fine wrinkles around the eyes, enhancing skin elasticity in the treated area. This treatment led to the following improvements:
- Fine Lines and Wrinkles Around the Eyes
- Appearance of Eyebags
- Dark Circles and Crow’s Feet
Additionally, another study involved participants randomly assigned to experimental and control groups to compare the 16-week efficacy of fractional laser combined with Rejuran versus fractional laser combined with saline. Adding polynucleotides (PN) to conventional fractional laser treatment resulted in better wound healing and post-operative scar prevention after thyroidectomy.
Post-Marketing Surveillance and Reported Side Effects
Post-marketing surveillance for medical devices involves continuous monitoring to identify any adverse events not detected during pre-approval research or studies. The US FDA’s Adverse Event Reporting System (FAERS) collects and analyzes data from healthcare providers and patients to ensure each product’s ongoing safety and efficacy.
Ongoing evaluation helps update product labeling and, if necessary, reevaluate the approval decision. The most common Rejuran side effects include mild to moderate transient swelling, redness, and bruising, which typically resolve within a few days.
Unfortunately, Rejuran Healer has yet to receive US FDA approval, so post-marketing surveillance for this skin booster is unavailable. This lack of approval may prompt medical professionals to recommend alternative skin boosters for their patients. Medical experts and PharmaResearch should conduct more long-term studies and gather post-marketing data to demonstrate its favorable safety and efficacy profile.
Continuous monitoring by the Korean FDA ensures that Rejuran remains a reliable treatment option for aesthetic concerns. Moreover, obtaining US FDA approval would enhance medical professionals’ trust in Rejuran’s effectiveness in addressing facial aesthetic issues.
Reassuring the Safety and Effectiveness of Rejuran
Despite the lack of US FDA approval, PharmaResearch’s clinical studies have demonstrated a strong safety profile for Rejuran. The treatment employs biocompatible polynucleotides, significantly reducing the risk of allergic reactions and adverse effects. Its regenerative properties facilitate cell growth and repair, improving skin texture and elasticity.
Although the treatment is appropriate for various skin types and conditions, Rejuran Healer must be administered by a licensed and trained medical professional to ensure patient safety and achieve optimal benefits. However, earning the approval of the US FDA can persuade more medical professionals and individuals to receive the skin booster for their aesthetic concerns.
Conclusion
Rejuran may have received the certifications and approval from Korea but has not received approval from the US FDA. This means that it has yet to undergo the rigorous evaluation process required by the Food and Drug Administration to deem it safe and effective for use in the United States.
While Rejuran may be available in other countries and regions, individuals should be cautious and seek advice from healthcare professionals before using it. Prioritizing safety and legal compliance when considering any medical product or treatment is essential. Individuals should always consult with qualified healthcare professionals and make informed decisions about its use based on reliable information.
FAQs
1. Has Rejuran received the US FDA approval?
Rejuran is not currently approved by the US FDA. It is essential to consult with a healthcare professional to understand its approval status and usage in your region.
2. Why is FDA approval significant?
FDA approval signifies that manufacturers consistently meet high-quality manufacturing standards, ensuring the safety and effectiveness of treatments reaching the market.
3. Can patients receive Rejuran Healer even if it is not FDA-approved?
The decision to use Rejuran should be made in consultation with a healthcare professional who can guide patients in determining safety, efficacy, and legal status in your region.
References
- 2023 ASPS Procedural Statistics Release. American Society of Plastic Surgeons. https://www.plasticsurgery.org/documents/news/statistics/2023/plastic-surgery-statistics-report-2023.pdf
- REJURAN® PN (polynucleotides). (n.d.). Medicaljj.net. Retrieved August 15, 2024, from https://medicaljj.net/wp-content/uploads/2020/09/REJURAN.pdf
