Only FDA-approved melasma treatment to re-launch after improvements to manufacturing process and supply chain.
For many dermatologists and general practitioners, Tri-Luma, the only FDA-approved melasma treatment with three active ingredients, is one of the key weapons in their armoury when it comes to treating melasma, so when its manufacturer, Galderma, announced that it would be temporarily unavailable, many health care practitioners were understandably concerned. Its return is bound to please just as many.
“The return of Tri-Luma will put a smile back on dermatologists’ faces as well as brighten their patients’ complexions,” says dermatologist, Dr Cheong Wai Kwong from the Specialist Skin Clinic and Associates. “With three potent ingredients (each acting in a different manner) packed into one cream, Tri-Luma has proven to be more effective than single-ingredient topical products in the treatment of hyperpigmentation skin conditions such as melasma. It is indeed a valuable tool for dermatologists in the fight against pigmentary disorders.”
According to Ms Dawn Lim, the product manager at Galderma responsible for the distribution of Tri-Luma in Singapore, “Tri-Luma was temporarily unavailable while Galderma were working to optimise aspects of the manufacturing process and supply chain to ensure the most stable product and reliable supply possible.”
Galderma re-launched Tri-Luma in Singapore in June of this year; now distributed under cold chain protocols. While the new cold chain product ensures a longer and more stable shelf life, Ms Lim assures us that, “all the other characteristics of the product, as well as the clinical profile are unchanged.”
Galderma is transiting to the cold chain storage Tri-Luma in all countries where it is registered. However, the timeline for the reintroduction differs from country to country according to the different local regulatory environments. The United States of America was the first country to switch to cold chain and Singapore is the first in South East Asia to supply the new product.
While cold chain storage can be ensured from manufacturer to the doctor’s clinic, healthcare practitioners know that once the medication is given to a patient there are no guarantees on how it will be stored. Ms Lim addresses concerns about risks to patients if they do not keep their prescribed Tri-Luma in cold chain condition.
“Tri-Luma is intended for the short-term (maximum of eight weeks) treatment of the dark spots associated with moderate-to-severe facial melasma and while we do not foresee a major safety hazard from cold chain interruption for such a period, Galderma does not encourage any deviation from the approved labelling,” Ms Lim explains.
She adds, “Continuous improvement is a part of Galderma’s core values and our technical and scientific teams will continue to seek further improvements of Tri-Luma to even better meet the needs of patients and healthcare practitioners, as we do with all our brands.”
“Pigmentation disorders are one of the strategic therapeutic areas for Galderma, and a major focus of our research and development (R&D) and medical activities, and Galderma are committed to continue bringing innovation in this field to the global market.”