Topical "Non-Aromatic Very Rich in Steranes" (NAVS) Naphthalan for the Treatment of Oral Mucosal Diseases

Summary

This study evaluates the effectiveness of topical NAVS naphthalan in the treatment of oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Half of participants with OLP and RAS will receive topical NAVS naphthalan in adhesive paste, while the other half will receive 0.05%-betamethasone dipropionate in adhesive paste. Our hypothesis is that NAVS could be efficient in the treatment of OLP and RAS, with effects comparable to that of topical steroids.

Timeline

Start

2010-12

Primary completion

2013-11

Completion

2013-11

Outcome

Missed primary endpoint

paper No significant differences in terms of OLP clinical signs (p = 0.84, η2 = 0.001) PMID 33831097 ↗

paper no significant differences between the groups in terms of lesion number (at days 3 and 5, p = 0.33 and p = 0.98, respectively) PMID 33831097 ↗

paper No evidence of differences between the two compared interventions was found. PMID 33831097 ↗

Publications

• Background Al-Hashimi I, Schifter M, Lockhart PB, Wray D, Brennan M, Migliorati CA, Axell T, Bruce AJ, Carpenter W, Eisenberg E, Epstein JB, Holmstrup P, Jontell M, Lozada-Nur F, Nair R, Silverman B, Thongprasom K, Thornhill M, Warnakulasuriya S, van der Waal I. Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerations. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103 Suppl:S25.e1-12. doi: 10.1016/j.tripleo.2006.11.001. Epub 2007 Jan 29.
• Background Khandwala A, Van Inwegen RG, Alfano MC. 5% amlexanox oral paste, a new treatment for recurrent minor aphthous ulcers: I. Clinical demonstration of acceleration of healing and resolution of pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Feb;83(2):222-30. doi: 10.1016/s1079-2104(97)90009-3.
• Background Lehner T. Autoimmunity in oral diseases, with special reference to recurrent oral ulceration. Proc R Soc Med. 1968 May;61(5):515-24. doi: 10.1177/003591576806100543. No abstract available.
• Background Lo Muzio L, della Valle A, Mignogna MD, Pannone G, Bucci P, Bucci E, Sciubba J. The treatment of oral aphthous ulceration or erosive lichen planus with topical clobetasol propionate in three preparations: a clinical and pilot study on 54 patients. J Oral Pathol Med. 2001 Nov;30(10):611-7. doi: 10.1034/j.1600-0714.2001.301006.x.
• Background Neppelberg E, Johannessen AC, Jonsson R. Apoptosis in oral lichen planus. Eur J Oral Sci. 2001 Oct;109(5):361-4. doi: 10.1034/j.1600-0722.2001.00081.x.
• Background Nolan A, Baillie C, Badminton J, Rudralingham M, Seymour RA. The efficacy of topical hyaluronic acid in the management of recurrent aphthous ulceration. J Oral Pathol Med. 2006 Sep;35(8):461-5. doi: 10.1111/j.1600-0714.2006.00433.x.
• Background Piboonniyom SO, Treister N, Pitiphat W, Woo SB. Scoring system for monitoring oral lichenoid lesions: a preliminary study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Jun;99(6):696-703. doi: 10.1016/j.tripleo.2004.07.013.
• Background Rodriguez M, Rubio JA, Sanchez R. Effectiveness of two oral pastes for the treatment of recurrent aphthous stomatitis. Oral Dis. 2007 Sep;13(5):490-4. doi: 10.1111/j.1601-0825.2006.01327.x.
• Background Zakrzewska JM, Chan ES, Thornhill MH. A systematic review of placebo-controlled randomized clinical trials of treatments used in oral lichen planus. Br J Dermatol. 2005 Aug;153(2):336-41. doi: 10.1111/j.1365-2133.2005.06493.x.
• Rogulj AA, Z Alajbeg I, Brailo V, Skrinjar I, Zuzul I, Vucicevic-Boras V, Alajbeg I. Topical NAVS naphthalan for the treatment of oral lichen planus and recurrent aphthous stomatitis: A double blind, randomized, parallel group study. PLoS One. 2021 Apr 8;16(4):e0249862. doi: 10.1371/journal.pone.0249862. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NAVS Naphthalan	Unknown	—	Topical
Comparator	betamethasone dipropionate	Small molecule	0.05 %	Topical

Indications