TAGS: Skin Care
Sirona Biochem has announced results of a clinical trial performed in the Peoples Republic of China (China) using Sirona’s novel skin lightening agent TFC-1067. Sirona’s TFC-1067 once again demonstrated significant clinical lightening effect without any reported adverse effects.
Clinical Testing of TFC-1067
A major distributor of cosmetics materials in China arranged clinical testing of TFC-1067 to be done by a select group of its key cosmetic customers. The formulation used in the studies was the same as that used in Sirona’s first clinical trial in the USA by Dr. Zoe Draelos. The clinical trial design protocols and the testing was conducted independently of Sirona by the cosmetic companies. The studies were conducted in Guangzhou, China.
The Trials
- A total of 60 participants were involved in the studies conducted over several sites
- All participants applied the formulation with TFC-1067 twice daily to the face
- Each study duration was 4 weeks
- During the 4 weeks 90% of participant reported a brightening effect with TFC-1067
- Sirona is informed by the distributor that a second set of trials with Sirona’s improved, next generation, formulation is underway
Positive Testing Result on Asian skin
Dr. Géraldine Deliencourt-Godefroy, Chief Scientific Officer of Sirona Biochem stated,
“These are excellent clinical results. Based on the outcome from our first clinical trial, we are pleased to see such results for the short 4-week duration of the testing. This positive testing result on Asian skin with the observed lightening effect supports the clinical effect of TFC-1067 over different skin types. A longer trial is required to assess dyschromia which was assessed in Sirona’s US based clinical trial. Sirona will await feedback on the further testing currently ongoing in China with our new formulation.”
“No clinical safety issues were reported with TFC-1067 during the trial. TFC-1067 has shown a lightening effect over a short clinical trial on Asian skin types.” reports Dr. Howard Verrico, CEO of Sirona Biochem.
“Although we prefer to conduct trials with a double blinded protocol using a comparative compound and a longer trial duration as we arranged in the USA, it was important to have these cosmetic companies perform their own clinical testing independently and be confident of the results. TFC-1067 continues to deliver excellent clinical results as anticipated by our preclinical assays. A strong commercial interest in TFC-1067 is already reported by the distributor based on current results.”
“Sirona’s team remains dedicated to work towards entering this market with a safe and effective alternative to current options. We are moving forward on building our relationship with the Chinese distributor with more positive news anticipated near term”, Dr. Verrico concluded.
The global skin lightening market is estimated to grow to US$31.2 billion by 2024. Asia makes up the largest and fastest growing segment of the market. A World Health Organization survey reported that nearly 40 per cent of women polled in China said they regularly used whitening products many of which are toxic.
Source: Sirona Biochem