The controversy surrounding Rejuran, a leading skin treatment product in South Korea, has resurfaced following revelations about the retraction of a past Phase 3 clinical study.
On September 1, PharmaResearch issued a statement clarifying that the retraction of the study was not due to issues with the clinical trial results or the safety and efficacy of Rejuran. Instead, it was attributed to inaccuracies in the disclosure of funding support and conflicts of interest.
The study in question was published in 2014 in the international journal Journal of Korean Medical Science (JKMS). It evaluated the effectiveness and safety of Rejuran, which contains polynucleotide (PN) components, compared to hyaluronic acid products in improving crow's feet in 72 adult participants.
This paper was retracted in 2016. According to the retraction notice from JKMS, the authors stated they had no financial conflicts with related companies. However, it was later confirmed that the clinical trial costs were supported by the manufacturer, and one of the co-authors was affiliated with PharmaResearch at the time.
The journal deemed this a case of inaccurate disclosure regarding the funding source and conflicts of interest. However, the retraction notice did not cite data manipulation or issues with the efficacy or safety of Rejuran as reasons for the withdrawal.
Rejuran was approved in South Korea in 2014 as a medical device for temporarily improving facial wrinkles, and subsequent products have been launched since then.
Nonetheless, caution is advised regarding the academic evidence supporting PN treatments. A systematic review published last year in the Journal of Cosmetic Dermatology analyzed nine studies related to PN in aesthetic medicine, involving a total of 219 participants, suggesting potential for wrinkle reduction and improvements in skin texture and elasticity. However, the quality of the included studies was rated as low to moderate, and the researchers emphasized the need for more rigorous, high-quality studies to confirm efficacy and safety. The 2014 Rejuran Phase 3 study, which was retracted in 2016, was among those analyzed.
PharmaResearch stated, "We are comprehensively reviewing various clinical and academic research data accumulated to date, including approval documents from domestic and international regulatory agencies, to continuously verify the safety and efficacy of our products."
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.