With data from the Pharmaceuticals and Medical Devices Agency (PMDA), the company estimates that its new active is the first quasi-drug to be approved for manufacture and sale in about a decade.
The company told CosmeticsDesign-Asia that it developed the ingredient as it saw the need for a new whitening solution. “Whitening is a function that has a very high need from women, including Japanese," said the company. "Therefore we believe that the trend is unlikely to change in units of several years."
Study for efficacy
The Japanese beauty manufacturer explained that its new active ingredient, dubbed MKS-518, prevents spots and freckles by inhibiting melanin accumulation.
It revealed that the active has been in “careful” development for over 10 years, with an emphasis on safety from the stage of ingredient exploration.
“With the high safety and effectiveness recognised by the Ministry of Health, Labour and Welfare, we were able to obtain approval for the manufacture and sale,” said the company in a statement.
To study the efficacy of the whitening active, Pola Orbis conducted a 28-day study with 30 Japanese women and men.
The subjects were observed by a dermatologist, who compared the degree of pigmentation. It was found that compared to the control group that was given a placebo, the active ingredient significantly inhibited pigmentation in the experimental group.
Additionally, the subjects in the experimental group observed improvement in their skin condition.
The company said that the test they conducted was in accordance with the guidelines on pigmentation measurement and the effectiveness analysis method set by the Japan Cosmetics Industry Association (JCIA).
Emphasis on safety
In order to determine the long-term safety of MKS-518, the company conducted another year-long test with 132 Japanese female volunteers.
In accordance with clinical evaluation guidelines set by Ministry of Health, Labor and Welfare and under the supervision of a specialist dermatologist.
The company noted that side effects such as vitiligo were not observed in its subjects during this study.
In addition to the study, the company said a safety review committee led by a dermatologist was put in place to objectively evaluate the safety of MKS-518.
“As a result of strict deliberation by multiple dermatologists, there were no particular problems in safety recognised,” said the company. “At Pola Orbis, we would like to deliver this product to many customers as a whitening cosmetic product that you can safely use.”
Plans for MKS-518
Following the approval, Pola Orbis said that the company is already planning to incorporate the new active ingredient in its products. The company revealed that it is scheduled to be released from the Pola brand. However the release date is undecided.
Pola Orbis’s beauty portfolio consists of popular brands such as Japanese beauty brand Orbis, THREE, as well as Australian brand Jurlique.