top of page

Why should clinical trials be carried out for cosmetic innovations?


Why should I do clinical trials for cosmetic innovation?

Clinical trials are crucial for driving innovation and improving products in the personal care industry. They provide a structured framework to evaluate the safety, efficacy, and performance of new formulations, treatments, and skincare technologies. By participating in these trials, individuals contribute to advancing product development, ensuring better solutions for future consumers, and gaining early access to cutting-edge personal care innovations. 


Phases of a clinical trial

A clinical trial is a structured process designed to evaluate the safety and effectiveness of a product. The process consists of several phases;


Phase 0: Initial testing is conducted to assess the product's safety and functionality. 

Phase 1: Around <50 healthy subjects are recruited, to assess the product's safety on human skin. 

Phase 2: Recruiting around 5-100 patients, to evaluate the product's effectiveness and confirm safety for its intended use.

Phase 3: More than 300 patients (up to 3000), to validate safety and efficacy in a diverse population. 

Phase 4: Monitor the product's performance and safety after its commercial launch, to identify long-term effects, rare reactions, or opportunities for product improvement.


Each phase has a specific purpose and is categorized accordingly (Kandi & Vadakedath, 2023).


Importance of evidence-based practices

Clinical trials supports the importance of evidence-based practices, ensuring that formulations are rigorously tested for safety, efficacy, and measurable benefits. 


Efficacy validation: Clinical trials play a crucial role in confirming the effectiveness of skincare products. For example, studies have demonstrated notable enhancements in skin concerns such as wrinkles and hydration levels following the use of specific formulations, like peptide serums (Draelos, Kononov & Fox, 2016).


Guiding clinical standards: Data from clinical trials contribute to the development of dermatological standards and treatment protocols, enhancing patient care and outcomes (Kottner et al., 2019).


Diverse participant group: In clinical trials it is possible for researchers to recruit a broad range of participants, including adults and children, for in-depth studies. 


Focusing on specific conditions: Clinical trials can focus on common skin concerns, such as aging, acne, and dermatitis, enabling targeted research that directly addresses the needs of particular groups.


Combination treatments: Research frequently investigates the effectiveness of combination therapies, which can improve treatment results. Clinical trials have shown that multi-ingredient products can greatly enhance various skin attributes, including texture and tone (Herndon et al., 2015).


Targeting microbiome: By analyzing participant’s skin microbiomes, researchers can identify specific strains that may be beneficial for individual skin types (Theodorou et al., 2024).


Conclusion

In conclusion, clinical trials play a crucial role in confirming product effectiveness, ensuring safety, and supporting evidence-based practices. They drive innovation, comply with regulatory requirements, and enhance patient outcomes, making them an essential aspect of research and product development.


References

Draelos ZD, Kononov T, Fox T. An Open Label Clinical Trial of a Peptide Treatment Serum 

and Supporting Regimen Designed to Improve the Appearance of Aging Facial Skin. J Drugs Dermatol. 2016 Sep 1;15(9):1100-6. PMID: 27602972.


Herndon JH Jr, Jiang L, Kononov T, Fox T. An Open Label Clinical Trial of a Multi-Ingredient 

Anti-Aging Moisturizer Designed to Improve the Appearance of Facial Skin. J Drugs Dermatol. 2015 Jul;14(7):699-704. PMID: 26151786.


Kandi V, Vadakedath S. Clinical Trials and Clinical Research: A Comprehensive Review. 

Cureus. 2023 Feb 16;15(2):e35077. doi: 10.7759/cureus.35077. PMID: 36938261; PMCID: PMC10023071.


Kottner J, Hahnel E, El Genedy M, Neumann K, Balzer K. Enhancing SKIN health and safety 

in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial. Trials. 2019 May 29;20(1):302. doi: 10.1186/s13063-019-3375-7. PMID: 31142364; PMCID: PMC6542085.


Theodorou IM, Kapoukranidou D, Theodorou M, Tsetis JK, Menni AE, Tzikos G, Bareka S, 

Shrewsbury A, Stavrou G, Kotzampassi K. Cosmeceuticals: A Review of Clinical Studies Claiming to Contain Specific, Well-Characterized Strains of Probiotics or Postbiotics. Nutrients. 2024 Aug 2;16(15):2526. doi: 10.3390/nu16152526. PMID: 39125405; PMCID: PMC11314542.

Comments


Commenting has been turned off.
bottom of page