Safety of a formulation containing chitosan microparticles with chamomile: blind controlled clinical trial.
Danielle Cristina Garbuio, Cristina Mara Zamarioli, Maísa Oliveira de Melo and 3 others
PMID 30517572WHAT IT FOUND
A chamomile and chitosan formulation applied to healthy forearms for 28 days did not cause irritation or peeling.
Hydration increased at the chamomile site and one control, but water loss increased at all sites.
Key findings
01In 30 analysed participants, the formulation did not significantly change erythema or melanin from start to end at any application site, no desquamation was observed, and one participant reported mild pain.
02Skin water loss increased at all four evaluated sites, and untreated controls were included.
03Hydration increased significantly at the chamomile site and the right control, and subjective hydration improved in all participants at the chamomile and lanolin sites by the final day.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The trial was non-randomized, and the exact amount of product applied was not measured. It tested only intact forearm skin in healthy volunteers, so it does not show safety or benefit on wounds, damaged skin, or patient populations. 35 participants were allocated and 30 were analysed at the end; one participant was removed for local irritation and four missed the final visit. Skin water loss increased at untreated control sites too, so the barrier change may not be due to the formulation. The authors suggest a possible photoprotective effect from melanin changes, but the change at the chamomile site was not statistically significant.
The easy way to misread this
Do not read this as evidence that the formulation prevents or treats pressure injuries. It was a small, non-randomized safety test on intact forearm skin in healthy volunteers, and the authors said future studies are needed for lesions such as pressure injuries.