Are you concerned about the talk of sunscreen being unsafe?
Spaulding Clinical is a contract research organization. The FDA turned to us to conduct a clinical trial evaluating the absorption of four commercially available sunscreens. The results of our Maximum Usage Trial (MUsT) has been published in The Journal of the American Medical Association (JAMA).
The report can be summarized in one sentence:
The objective of this clinical trial was to determine whether four commercially available sunscreen ingredients are absorbed into the systemic circulation when applied under maximum use conditions.
The results of these foundational studies confirm what has been suspected for a long time – that ingredients in sunscreen are absorbed into the bloodstream. The study didn’t determine – nor did it set out to – whether sunscreen is safe or unsafe. Further studies are needed to determine the clinical significance of the findings.
Spaulding Clinical Research was contracted by the FDA to gather data relating to the absorption of four commercially available sunscreen formulations into the bloodstream. We conducted a randomized clinical trial and found conclusive evidence that the four key ingredients we were tracking – avobenzone, oxybenzone, octocrylene and ecamsule – all were absorbed into the bloodstream.
We have already been contacted by companies wanting to have their products tested in relation to this study and we anticipate more needing to do so. More information on the FDA’s work in this area can be found here: Shedding New Light on Sunscreen Absorption
This type of clinical trial seeks to show the amount of active ingredient that enters the bloodstream after an amount is applied that matches what “maximum use” conditions would be. The May 2018 guidance from the FDA defines what a Maximum Usage trial needs to entail for Sunscreen products. All pharmaceutical companies with prescription products that are topically applied must also conduct a maximum usage trial on their product which has been a requirement for decades. Review the FDA’s statement on maximum usage.
There is an abundance of data about the harmful effects of exposure to the sun. Sunscreen has been shown to provide significant protection from these effects. We are aligned with the FDA’s position on sunscreen that “these results do not indicate that individuals should refrain from the use of sunscreen.”
Maximum usage trial research has been enforced by the FDA for decades. Since our inception in 2008, Spaulding Clinical has been involved in many of these trials, across a variety of therapeutic areas. These areas include topical dermatology, infectious disease, women’s health and endocrinology, among others.
The Company operates a 200-bed, fully paperless, Clinical Pharmacology Unit featuring 96, full 12-lead telemetry beds and a 12-bed unit for First-in-Human /SAD/MAD trials.
Spaulding Clinical’s specialties include Phase I Drug Development and Core ECG Laboratory Services, Clinical Pharmacology Research, Biostatistics/Data Management, Cardiac Core Lab Services, Statistical Analysis, TQT Studies, First-in-human Studies, SAD/MAD Studies, BA/BE Studies, Drug Interaction and Food Effect Studies.
Spaulding Clinical, as the most experienced clinical research organization, can help you quickly design and implement a study and smoothly navigate you through a trial to achieve compliance.
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