An interventional study of Capsaicin oral gel 0.025% and Capsaicin oral gel 0.01% in Burning Mouth Syndrome, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-14.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Treatment
Burning mouth syndrome (BMS) is characterized by a bilateral burning sensation in the anterior tongue, hard palate and lips in the absence of any clinical or laboratory findings. The term syndrome implicates the simultaneous presence of oral dryness (xerostomia) and altered taste (dysgeusia) in addition to the burning sensation in the oral mucosa. BMS is most often seen in women and is more frequent during menopause. The etiology and pathogenesis are still unclear but recent studies suggest that BMS is a neuropathic pain condition.
The objectives of the study are:
Data which support the hypothesis that BMS is a neuropathic pain condition include amongst others a recent clinically controlled study that has shown up-regulation of TRPV1-positive nerve fibres in tongue mucosa in patients with BMS. The vanilloid receptor-1 (TRPV1) is a voltage-dependent cation channel expressed by the unmyelinated C-nociceptive nerve fibres and the receptor may be activated by capsaicin (from chili peppers), heat and H+. Capsaicin binds to the TRPV1 receptor causing depolarization of the C-nociceptors. Prolonged activation of these neurons by capsaicin depletes pre-synaptic substance P and makes them unable to report pain.
44 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.
This study's enrollment of 22 is below the median of 42 across 35 interventional studies indexed under Burning Mouth Syndrome.
Browse Burning Mouth Syndrome studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Other: Capsaicin oral gel 0.01%
Other: Capsaicin oral gel 0.025%
Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
Also known as: Capsicum, extract from chilipepper
Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
Also known as: Capsicum, extract from chilipepper
Primary outcome: To evaluate the efficacy and safety of topical application of capsaicin oral gel (using to different concentrations) to relieve the burning sensation in patients with BMS and alleviate BMS related symptoms.
Time frame: 6 months
To characterize the localization and distribution of peripheral nerve fibres, neuropeptides like substance P, calcitonin gene-related peptide, NGF, NGF-R, PGP 9.5 neuronal marker and TRPV1 as well as inflammatory/structural changes.
Time frame: 6 months
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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University of Copenhagen