New technique used patient’s blood; HSA says study did not comply with guidelines for smoothing out wrinkles by using the patient’s own blood. But a clinical trial by Singapore doctors has hit a snag. An inspection by the Health Sciences Authority (HSA) found that the way the study was being conducted did not comply with its guidelines. The trial was then terminated by an independent panel of experts overseeing it.
The technique that was being tested is called PRP skin regeneration therapy. It is used to treat fine wrinkles around the eyes and lips, acne marks, bags and dark circles under the eyes, and saggy skin. Blood is drawn from the patient and spun in a tube for eight minutes to produce a substance called platelet-rich plasma (PRP).
The PRP is drawn from the tube into a small syringe and calcium chloride solution is added to it. The mixture is then injected into the patients at the trouble spots. The doctors in charge of the trial, Dr Tan Kok Leong and Dr Gerald Tan, are general practitioners who run their own clinic – the Revival Medical Clinic in Novena. They submitted an aesthetic clinical trial application to the HSA for review in July.
In an e-mail reply, the HSA spokesman said yesterday that it had conducted a GCP (Good Clinical Practice) inspection. This inspection found that the constitution and operations of the Independent Review Board – the panel overseeing the study – did not comply with the Singapore Guidelines for Good Clinical Practice. It is not known how many patients were involved in the trial.
Clinical trials typically involve about 200 patients and require doctors to track their results. They are essential for the development of new and improved therapies, which is why it is important that they meet high scientific and ethical standards. The trials also need to be meticulously conducted, recorded, terminated, and reported according to pre-established criteria. Doctors who flout the guidelines may be referred to the Singapore Medical Council (SMC) for a disciplinary hearing where,
depending on the case, they could be fined or even suspended. However, there is no suggestion of this happening in the PRP trial. Its principal investigator, Dr Tan, told Lianhe Zaobao that he intends to take his clinical trial to Cambodia, but did not go into details. Neither doctor could be reached by The Straits Times for comment yesterday.
Cosmetic treatments were thrust into the spotlight two years ago after the health authorities raised concerns about the number of doctors branching out into lucrative beauty treatments, some of which are banned in other countries. Since November 2008, doctors dabbling in aesthetic treatments have had to get permission before they can offer a range of therapies. The permission must be given by the Aesthetic Practice Oversight Committee, under the SMC.