naphthalan and betamethasone-17-21-dipropionate

To evaluate the effectiveness of non-aromatic very rich in steranes (NAVS) naphthalan in the treatment of oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Null hypothesis was that there would be no difference between NAVS and topical steroids in the treatment of OLP and RAS.. The study consisted of two sub-trials conducted as randomized, double-blind controlled studies: first included OLP patients and second patients with RAS. Patients received either NAVS or 0.05% betamethasone dipropionate. Primary outcomes were activity score (OLP patients), No of lesions and lesion diameter (RAS patients) and pain intensity (VAS) while secondary outcome included the impact of the disease on quality of life assessed by Oral health impact profile (OHIP 14).. No significant differences in terms of OLP clinical signs (p = 0.84, η2 = 0.001) and responses on the OHIP-14 (p = 0.81, η2 = 0.002) or on VAS (p = 0.14, η2 = 0.079) between NAVS and betamethasone groups were observed. In RAS patients, no significant differences between the groups in terms of lesion number (at days 3 and 5, p = 0.33 and p = 0.98, respectively), lesion diameter (days 3 and 5, p = 0.24 and p = 0.84, respectively) were observed. However, in NAVS group a significant reduction of lesions diameter was observed on the 3rd day, while in betamethasone group a significant reduction in lesions diameter was evident only after the 5th day. No significant differences in VAS (p > 0.05) and the OHIP-14 (p > 0.05) between groups were found.. No evidence of differences between the two compared interventions was found.. Retrospective registration of this trial was conducted in ClinicalTrials.gov on September 30, 2016; trial registration number: NCT02920658. https://clinicaltrials.gov/ct2/show/NCT02920658?term=NAVS&draw=2&rank=4.

Topics: Administration, Topical; Aged; Anti-Inflammatory Agents; Betamethasone; Female; Humans; Lichen Planus, Oral; Male; Middle Aged; Naphthalenes; Quality of Life; Stomatitis, Aphthous

"Non-Aromatic Very rich in Steranes" (NAVS) naphthalan is a purified natural oil derivative, abundant in steranes (geogenic "steroids"). The purpose of this study was to evaluate the effectiveness of NAVS in the treatment of oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS). We used NAVS oil in adhesive paste in 11 patients with clinically and histologically proven OLP (open label), and in 7 patients with RAS (double blind randomized; topical betamethasone in adhesive paste used as control). The severity of the OLP lesions was objectively scored. The number and diameter of RAS lesions were assessed on days 0, 3, and 5. The intensity of pain and discomfort was determined using visual analogue scale (VAS) and "Oral health impact profile" (OHIP-14) before and after therapy. OLP cumulative activity scores on days 0 and 28 were 101.5 and 48.5, respectively (t=5.99; P=0.0001). Using NAVS for 28 days resulted in 52.2% overall clinical improvement. Cumulative OHIP-14 scores on days 0 and 28 were 210 and 142, respectively (t=5.65; P=0.0002). Out of a total of 7 patients with RAS, 4 of them were treated with NAVS and 3 with topical corticosteroids. There were no statistically significant differences in improvement rate between the two groups (lesion number (day 3 P=0.29; day 5 P=0.32); lesion diameter (day 3 P=0.64; day 5 P=0.74)). NAVS successfully reduced the clinical signs and symptoms of OLP, and reduced the number, diameter, and symptoms in patients with RAS, statistically comparable with corticosteroids.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Betamethasone; Double-Blind Method; Female; Humans; Lichen Planus, Oral; Male; Naphthalenes; Ointments; Pain Measurement; Pilot Projects; Recurrence; Severity of Illness Index; Stomatitis, Aphthous; Treatment Outcome