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Trial record 67 of 272 for:    Betamethasone

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

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ClinicalTrials.gov Identifier: NCT02920658
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
Ministry of Science, Education and Sport, Republic of Croatia
Information provided by (Responsible Party):
Ivan Alajbeg, University of Zagreb

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.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Recurrent Aphthous Stomatitis Drug: NAVS Naphthalan Drug: 0.05% Betamethasone dipropionate Phase 2

Detailed Description:

Non-Aromatic-Very rich in Steranes (NAVS) naphthalan is a transparent, earth mineral oil prepared by a complex set of procedures of separations and refining, starting with a special oil that is used as the raw material for brown naphthalane, which has been successfully used in the treatment of psoriasis. In order to remove potentially mutagenic polycyclic aromatic hydrocarbons (PAHs), liquid chromatography was used. UV / VIS (ultra violet / visible light) spectrophotometry confirmed that PAHs were bellow detection threshold. Additionally, the precise distillation process has concentrated steranes, which are important bioactive constituents. Since steranes contain similar chemical structure as well-known bioactive substances, such as vitamin D3 and steroid hormones, the assumption is that NAVS is effective in the treatment of oral diseases which have immune genesis such as OLP and RAS.

Today, topical steroid preparations are considered as first-line therapy for many chronic immune-mediated inflammatory diseases of the oral mucosa. Risks of short-term use of topical corticosteroids are clinically insignificant, while their long-term use is not recommended because of potential side effects, such as mucosal atrophy, secondary infection with Candida albicans, possible systemic absorption and suppression of the adrenal gland.

Study participants are adult patients of the Department of Oral Medicine, School of Dental Medicine in Zagreb, with a clinically and histologically proven OLP or RAS in the acute stage of the disease.The treatment outcome of the OLP patients will be measured by clinical improvement and subjective symptomatic relief. The outcome of RAS patients treated by NAVS naphthalan or by betamethasone will be measured clinically by the decrease in number and size of lesions as well as by subjective symptomatic relief over treatment period. One member of the team, who will not evaluate the therapeutic effect, will took care of the allocation of test and control preparations. At the end of the study, a randomization code will be opened and statistically analysed. In both clinical and subjective domains, of both clinical conditions, the improvement rate will be measured by comparing these readings, as the percentual reduction of clinical scores and symptoms. Since the data will not be normally distributed, methods of nonparametric statistics will be used: Wilcoxon test for dependent and Mann-Withney test for independent samples. Baseline intergroup differences will be assessed by Mann-Withney test. For the interpretation of the average values, medians and interquartile ranges (IQR) will be used. Fisher exact test will be used to compare gender representation among the groups. Statistical analysis will be performed using MedCalc Software 13.0.0.0 (Acacialaan 22, 8400 Ostend, Belgium). P value lower then 0.05 (p< 0.05) will be considered statistically significant.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Nonaromatic Naphthalan - Composition Study and Biological Effects on Epithelial Tissues
Study Start Date : December 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013


Arm Intervention/treatment
Experimental: NAVS Naphthalan
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
Active Comparator: 0.05% Betamethasone dipropionate
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
Other Name: Beloderm




Primary Outcome Measures :
  1. The change of presence of reticulation, erythema and ulceration on mucosal surfaces [ Time Frame: 28 days per patient ]

    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.


  2. The change in the number of RAS lesions [ Time Frame: 5 days per patient ]
    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.

  3. The change in the diameter of RAS lesions [ Time Frame: 5 days per patient ]
    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.

  4. The change of pain intensity and discomfort in OLP patients [ Time Frame: 28 days per patient ]
    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.

  5. The quality of life change in OLP patients [ Time Frame: 28 days per patient ]
    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.

  6. The change of pain intensity and discomfort in RAS patients [ Time Frame: 5 days per patient ]
    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.

  7. The quality of life change in RAS patients [ Time Frame: 5 days per patient ]
    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.


Secondary Outcome Measures :
  1. Adverse reactions to treatment modalities in OLP patients [ Time Frame: 28 days per patient ]
    In OLP patients application of both treatment modalities lasts for 28 days. The occurrence of oral Candidal infection or irritation will be recorded by clinician on day 28. The frequency of each will be compared between two treatment groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920658


Locations
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Croatia
School of Dental medicine, University of Zagreb
Zagreb, Croatia, 10 000
Sponsors and Collaborators
Ivan Alajbeg
Ministry of Science, Education and Sport, Republic of Croatia
Investigators
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Principal Investigator: Ivan Alajbeg, PhD University of Zagreb School of Dental Medicine

Publications:

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Responsible Party: Ivan Alajbeg, Professor of Oral Medcine, University of Zagreb
ClinicalTrials.gov Identifier: NCT02920658     History of Changes
Other Study ID Numbers: 065-0650445-1277
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, de-identified data are available upon request.
Keywords provided by Ivan Alajbeg, University of Zagreb:
NAVS Naphthalan
Betamethasone dipropionate
Topical treatment
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Lichen Planus, Oral
Stomatitis
Stomatitis, Aphthous
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents