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

NCT02920658 | Completed Phase 2 DMC

• 1 other identifier: 065-0650445-1277
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Lichen Planus; Recurrent Aphthous Stomatitis

Keywords

NAVS Naphthalan; Betamethasone dipropionate; Topical treatment

Outcome Measures

Primary Outcomes (7)

• The change of presence of reticulation, erythema and ulceration on mucosal surfaces

  Clinical improvement of OLP lesions after treatment will be scored (Pibooniyom et al.,2005). This clinical scale measures the presence of reticular, erythematous and ulcerative lesions on oral mucosal surfaces, providing a score by adding those values. Investigator will assess patients' lesions on oral mucosal surfaces, on day 0 and day 28 and provide score for each assessment. The change of this score between the two time points is a measure of clinical efficacy of applied treatment modality. Calibration process : three examiners independently reviewed and evaluated photo of the individual patient. The second evaluation of photographs was a week after to assess the objectivity of the reading on the first visit. Once the examiners reviewed the photographs twice with one-week gap, the obtained results were analysed using Spearman "rank" correlation to determine intra- and inter-observer reliability.

  28 days per patient

• The change in the number of RAS lesions

  The number of RAS lesions will be recorded on day 0 and on day 5 after the start of treatment (Khandwala et al, 1997). The change in the number of lesions between the two time points is a measure of clinical efficacy of applied treatment modality.

  5 days per patient

• The change in the diameter of RAS lesions

  The change in the diameter of RAS lesions (in millimeters) will be recorded on day 0 and on day 5 after the start of treatment (Khandwala et al, 1997). The change in the cumulative diameter of lesions between the two time points is a measure of clinical efficacy of applied treatment modality.

  5 days per patient

• The change of pain intensity and discomfort in OLP patients

  The intensity of pain and discomfort will be determined using a 100 mm visual analog scale (VAS) on day 0 and day 28. The change in the amount between the two time points is a measure of clinical efficacy of applied treatment modality.

  28 days per patient

• The quality of life change in OLP patients

  The quality of life for OLP patients will be determined using "Oral health impact profile"(OHIP-14) questionnaire on day 0 and day 28. The change in the amount between the two time points is a measure of clinical efficacy of applied treatment modality.

  28 days per patient

• The change of pain intensity and discomfort in RAS patients

  The intensity of pain and discomfort will be determined using a 100 mm visual analog scale (VAS) 30 and 60 minutes after the application of the therapeutic agent at home. The change in the amount between the two time points is a measure of clinical efficacy of applied treatment modality.

  5 days per patient

• The quality of life change in RAS patients

  The quality of life for RAS patients will be determined using "Oral health impact profile"(OHIP-14) questionnaire on day 0 and day 5. The change in the amount between the two time points is a measure of clinical efficacy of applied treatment modality.

  5 days per patient

Secondary Outcomes (1)

• Adverse reactions to treatment modalities in OLP patients

  28 days per patient

Study Arms (2)

NAVS Naphthalan

EXPERIMENTAL

NAVS oil in adhesive powder in a volume ratio 2:1, to apply on the affected mucosa three times daily during 4 weeks for OLP patients; NAVS oil in adhesive powder in a volume ratio 2:1, to apply on the affected mucosa three times daily during 5 days for RAS patients

Drug: NAVS Naphthalan

0.05% Betamethasone dipropionate

ACTIVE COMPARATOR

0.05% Betamethasone dipropionate in adhesive powder in a volume ratio 1:1, to apply on the affected mucosa three times daily during 4 weeks for OLP patients; 0.05% Betamethasone dipropionate in adhesive powder in a volume ratio 1:1, to apply on the affected mucosa three times daily during 5 days for RAS patients

Drug: 0.05% Betamethasone dipropionate

Interventions

NAVS Naphthalan DRUG

NAVS Naphthalan

0.05% Betamethasone dipropionate DRUG

Also known as: Beloderm

0.05% Betamethasone dipropionate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• for OLP patients: adult patients with a clinically and histologically proven OLP (Al-Hashimi et al, 2007)
• for RAS patients: in the acute stage of the disease, according to Lehner (1968), at least 2 episodes per year

You may not qualify if:

• for OLP patients: younger than 18 years, hepatobiliary system diseases, lichenoid reaction (amalgam, drugs) or lichen planus with lesions in contact to restorative materials (Zakrzewska et al, 2005), the current comparative systemic or local anti-inflammatory treatment (antibiotics, corticosteroids, non-steroidal antirheumatic drugs, chemotherapeutics) (Lo Muzio et al, 2001; Nolan et al, 2006; Rodriguez et al, 2007) and pregnancy.
• for RAS patients: patients younger than 18 years, haematological deficits (assessed by complete blood count (CBC), iron (Fe), vitamin B12, hypersensitivity to toothpaste and oral mouth rinse solutions (assessed by medical history) (Nolan et al, 2006), pregnancy, inflammatory bowel disease (assessed by medical history), significant immunodeficiencies, current comparative systemic or topical anti-inflammatory treatment (antibiotics, corticosteroids, nonsteroidal antirheumatics, chemotherapeutics) (Lo Muzio et al, 2001; Nolan et al, 2006; Rodriguez et al, 2007).

Sponsors & Collaborators

• Ivan Alajbeg: lead
• Ministry of Science, Education and Sport, Republic of Croatia: collaborator

Study Sites (1)

School of Dental medicine, University of Zagreb

Zagreb, City of Zagreb, 10 000, Croatia

Location

Related Publications (10)

• 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.

  PMID: 17261375 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.

  PMID: 9117754 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.

  PMID: 4297643 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.

  PMID: 11722711 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.

  PMID: 11695759 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.

  PMID: 16918596 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.

  PMID: 15897856 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.

  PMID: 17714352 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.

  PMID: 16086745 BACKGROUND

• 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.

  PMID: 33831097 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral; Stomatitis, Aphthous

Interventions

betamethasone-17,21-dipropionate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Stomatitis

Study Officials

• Ivan Alajbeg, PhD

  University of Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Oral Medcine

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: September 30, 2016
• Study Start: December 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 30, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CR (1)