To determine the therapeutic efficacy of micro needling for transmucosal delivery of triamcinolone acetonide and hyaluronic acid on symptomatic oral lichen planus
Design
A parallel group, double blinded randomised trial (phase 3) on 10 patients. Randomized computer number generator will be used.
Settings and conduct
The subjects will be selected from OLP patients visiting the Oral Medicine Department of Shiraz University of Medical Sciences. Corticosteroid therapy (0.1% Triamcinolone acetonide (TA) mouth rinse twice a day for two months) and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be prescribed for all subjects during the study. However, the lesions in each group will be subjected to micro needling (MN) unilaterally with a Dermapen once a week for two weeks. Thereafter, 0.1% TA suspension and/or both 0.1% TA and 0.2% HA will be applied. Subjects who will be received HA in MN session, will be instructed to apply it on both sides twice a day for two weeks. Then, the outcome will be evaluated by two blinded oral medicine specialists and a statistical consultant.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1.subjects aged 18 years or older with bilateral symptomatic OLP lesions
2.Subjects who are willing to participate
Exclusion Criteria:
1.Lichenoid reactions
2.History of drug allergy
3. Use of medication for OLP treatment or anticoagulants
4. Having oral candidiasis
5. Self-reported pregnancy or lactation
Intervention groups
Group A:
•Control Side: Topical application of 0.1% triamcinolone acetonide (TA)
•micro needling (MN) Side: Using MN technique as an adjunct to topical application of 0.1% TA
Group B:
•hyaluronic acid (HA) Side: Topical application of 0.1% TA and 0.2% HA
•Combination Side: Using MN technique as an adjunct to topical application of both 0.1% TA and 0.2% HA
Main outcome variables
Pain level; Severity of the lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231213060357N1
Registration date:2024-02-17, 1402/11/28
Registration timing:prospective
Last update:2024-02-17, 1402/11/28
Update count:0
Registration date
2024-02-17, 1402/11/28
Registrant information
Name
Asma Sookhakian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 1592
Email address
asma.soukhakian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of micro-needle assisted transmucosal delivery of hyaluronic acid and triamcinolone for oral lichen planus treatment
Public title
Effectiveness of micro-needling for oral lichen planus treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects aged 18 years or older
Subjects diagnosed with OLP based on the clinical or histopathological findings according to the newest diagnostic approach published by American Academy of Oral and Maxillofacial Pathology in ۲۰۱۶
Subjects with bilateral symptomatic OLP lesions
Subjects who are willing to complete this clinical trial
Exclusion criteria:
Subjects with lesions that may be associated with lichenoid reactions
Subjects having a history of drug allergy
Subjects with a history of use of topical corticosteroids (in the past ۴ weeks) or systemic corticosteroids (in the past ۳ months) for oral lichen planus, other immunosuppressive treatments, retinoids, and anticoagulants
Subjects having oral candidiasis
Subjects with self-reported pregnancy or lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
A split-mouth randomized clinical trial will be performed in each patient with bilateral lichen planus lesions. Therefore, two different treatment plans will be performed in each patient.
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation will be performed using a computer random number generator to create a random number table. In more detail, subjects will be randomly attributed ۰ (group A) or ۱ (group B). Thereafter, lesions on the right side will be randomly attributed ۰ (G۱ in group A or G۳ in group B) or 1 (G۲ in group A or G4 in group B).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the intervention provider will aware of the treatment type, but to establish a blind evaluation, the scores for the parameters such as pain level and severity of lesions will be determined by two oral medicine specialists who will not involve in any step during patients' allocation, treatment delivery and micro needling. Therefore, they will be blinded to the type of intervention and study period. On the other hand, an independent statistician will perform the statistical analysis. It is important to note that every groups and the study subjects will have a code number to ensure his/her blinding (statistician). Therefore, this study will be double blind.
Placebo
Not used
Assignment
Parallel
Other design features
10 patients with bilateral lichen planus lesions will participate in this study. These patients will be divided into two groups with 5 subjects and the effectiveness of four different treatment plans will be determined and compared with each other. In this way, first the patients are randomly attributed to one of the two groups A or B, and then two different treatment plans will be performed in each patient with bilateral lesions. Therefore, two different treatment subgroups are defined in each group.The sample size estimation will be calculated based on a pilot study of 5 subjects in each group (A or B) at the 5% level of significance with power of 90%.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Dentistry-Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-12-20, 1402/09/29
Ethics committee reference number
IR.SUMS.DENTAL.REC.1402.084
Health conditions studied
1
Description of health condition studied
Oral Lichen Planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
Pain Level
Timepoint
At the beginning of the study (before the start of the intervention) and 14, 28, and 56 days after start
Method of measurement
Visual Analogue Scale
2
Description
Severity of the lesions
Timepoint
At the beginning of the study (before the start of the intervention) and 14, 28, and 56 days after start
Method of measurement
reticulation/erythema/ ulceration (REU) scoring system
Secondary outcomes
empty
Intervention groups
1
Description
Control group G 1: Control side in group A will be received topical 0.1% triamcinolone acetonide suspension (Exir, Iran) twice a day as the first line treatment during the study (for two months). Prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study.
Category
N/A
2
Description
Intervention group G 2: Micro-needling (MN) side in group A will be subjected to MN once a week for two weeks and then received topical application of 0.1% triamcinolone acetonide (TA) suspension (Exir, Iran). Topical application of 0.1% TA twice a day for two months and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study.
Category
Treatment - Drugs
3
Description
Intervention group G 3: Hyaluronic acid (HA) side in group B will be received topical 0.2% HA (Gengigel, Ricerfarma, Italy) twice a day for two weeks. Topical application of 0.1% triamcinolone acetonide suspension (Exir, Iran) twice a day for two months and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study.
Category
Treatment - Drugs
4
Description
Intervention group G 4: Combination side in group B will be subjected to MN once a week for two weeks and then received topical 0.2% Hyaluronic acid (HA) (Gengigel, Ricerfarma, Italy) and 0.1% triamcinolone acetonide (TA) suspension (Exir, Iran). Topical application of topical 0.2% HA twice a day for two weeks, 0.1% TA suspension twice a day for two months, and prophylactic antifungal therapy (fluconazole 200 mg once weekly) will be also prescribed during the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Medicine Department, Shiraz School of Dentistry
Full name of responsible person
Asma Sookhakian
Street address
Shiraz School of Dentistry, Ghasrodasht street
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3628 0112
Email
asma.soukhakian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
Shiraz University of Medical Science, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Asma Sookhakian
Position
Postgraduate Student of Oral and Maxillofacial Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrodasht street
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3628 0112
Email
asma.soukhakian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Zahed
Position
Associate Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrodasht street
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3628 0112
Email
maryamzhd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Asma Sookhakian
Position
Postgraduate Student of Oral and Maxillofacial Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrodasht street
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3628 0112
Email
asma.soukhakian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data can be shared after de-identifying individuals.
When the data will become available and for how long
Data will be available up to 6 months after publication.
To whom data/document is available
The researchers in academic and scientific institutions
Under which criteria data/document could be used
The researchers in academic and scientific institutions
From where data/document is obtainable
The data supporting the findings of this study will be available upon reasonable request from the corresponding author.
What processes are involved for a request to access data/document
The researchers in academic and scientific institutions can email the corresponding author and request for information.