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Two key clinical studies and FDA approval
demonstrated that ClearUP is a safe and effective
treatment for sinus pain associated with allergic
rhinitis and moderate to severe congestion.
1. Schenkel, E. J., Ciesla, R., & Shanga, G. M. (2018). Effects of nasal
dilator strips on subjective measures of sleep in subjects with
chronic nocturnal nasal congestion: a randomized, placebo-
controlled trial. Allergy, Asthma & Clinical Immunology, 14(1), 34
2. Katotomichelakis, M., Van Crombruggen, K., Holtappels, G., Kuhn,
F. A., Fichandler, C. E., Kuhn-Glendye, C. A., ... & Kastanioudakis,
I. (2017). A herbal composition of Scutellaria baicalensis and
Eleutherococcus senticosus shows vasocontrictive effects in
an ex-vivo mucosal tissue model and in allergic rhinitis patients.
Clinical Phytoscience, 3(1), 21.
of use. For example, subjects experienced
nasal stuffiness, blockage, and congestion
less frequently and were better able to
breathe through their noses.
• 73% preferred ClearUP Sinus Pain
Relief device to their current sinus pain
treatment(s).
Note:
Only two subjects experienced minor reddening of the skin
and one subject experienced an eyelid muscle twitch, both of
which resolved without treatment.
Study 2 was an open-label 4-week study and
did not have a control group or a placebo.
To address the uncertainty created by this
design, we conducted a literature review to
identify the magnitude of the placebo effect in
subjects with congestion that completed the
Congestion Quantifier 7 (CQ7) questionnaires.
The literature search identified two peer-
reviewed papers.
1,2
Placebo-treated subjects
reported an average reduction in CQ7 score of
-27% and -20% in the two studies. This range
of CQ7 score reductions was smaller than the
average CQ7 score reduction reported in Study
2 (-44%), indicating that ClearUP effectiveness
is above and beyond a placebo effect.
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