CTRI/2018/05/013796 [Registered on: 09/05/2018] Trial Registered Prospectively
Last Modified On:
17/02/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A Study of Tacrolimus Ointment of Intas Pharmaceuticals Limited, India in Patients having Inflammatory Condition with ulcer affecting mucous membranes inside the mouth
Scientific Title of Study
An Open-Label, Single Arm, Multi-Centered Study To Evaluate The Efficacy, Safety And Tolerability Of Lipid Based Tacrolimus Ointment 0.1% Of Intas Pharmaceuticals Limited, India In Patients of Oral Lichen Planus
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
0804-16, Version 1.0 Dated 12 October 2017
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Harshvardhan Shrivastava
Designation
Project Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department: Clinical Trial Management, Plot no. 38, Survey No. 388 Near Silver Oak Club,
S. G. Highway, Gota Ahmadabad GUJARAT 382481 India
Phone
07940202396
Fax
07940202021
Email
harshvardhan@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Falgun Vyas
Designation
Senior Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department: Clinical Trial Management, Plot no. 38, Survey No. 388 Near Silver Oak Club,
S. G. Highway, Gota Ahmadabad GUJARAT 382481 India
Phone
07940202354
Fax
07940202021
Email
falgunvyas@lambda-cro.com
Details of Contact Person Public Query
Name
Mr Harshvardhan Shrivastava
Designation
Project Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department: Clinical Trial Management, Plot no. 38, Survey No. 388 Near Silver Oak Club,
S. G. Highway, Gota Ahmadabad GUJARAT 382481 India
Phone
07940202396
Fax
07940202021
Email
harshvardhan@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals Ltd, 2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat, India, Tel. No. 07926576655, Fax No. 0792657-8862
Primary Sponsor
Name
Intas Pharmaceuticals Ltd
Address
2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat, India, Tel. No. 07926576655, Fax No. 0792657-8862
Lipid based tacrolimus ointment 0.1% of Intas Pharmaceuticals Ltd., India.
Dose: 1 cm ribbon spread is
recommended, Frequency: Four
times in a day, Route of
Administration: apply as a thin layer to all affected areas in oral cavity,
Total Duration of Therapy: 12 weeks / till complete healing of all baseline
lesions whichever comes first.
Comparator Agent
NA
NA
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female participants between 18 and 65 years of age (both inclusive) and willing to sign and provide a written informed consent form for participation in the study and agree to comply with study requirements.
2. Confirmed diagnosis of oral lichen planus based on history in combination with a compatible clinical appearance of lesional tissues.
3. Symptomatic OLP (Spontaneous or meal related oral pain) with a score of at least 35 mm on a visual analog scale for pain.
4. Male patients of child begetting potential and female patients of child bearing potential must be practicing either adequate contraception or abstinence from sex. Such female patients must not be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at the start of the study.
ExclusionCriteria
Details
1. Patients with active extra oral lichen planus lesions requiring management.
2. Patients with asymptomatic oral lichen planus.
3. Subjects who have received systemic immunosuppressants, oral retinoids or any other systemic therapies known or suspected to have an effect on oral lichen planus within 4 weeks prior to randomization in the study.
4. Subjects who have been treated with any topical therapy known or suspected to have an effect on lichen planus within the last one week prior to randomization in the study.
5. Subjects who have severe or recurrent systemic or generalized infections (bacterial, viral or fungal).
6. Subjects who have a clinically relevant liver disorder or renal disorder.
7. Subjects who have unstable or uncontrolled diabetes or hypertension.
8. Subjects must not have taken any potent CYP3A4 inhibitors within 14 days prior to randomization.
9. Subjects who are intended to be treated with any potent inhibitor of the co enzyme CYP450 3A4 during the course of study. Treatment with substrates or moderately potent inhibitors of CYP450 3A4 is permitted during the study, under close monitoring for adverse events during that period.
10. Hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin, etc.
11. Patient in need of concomitant treatments (while on study) that can be potentially effective on lichen planus lesions such as antimalarials, oral retinoids, steroids or immunosuppressive drugs
12. History or active presence of HIV and or hepatitis B and or hepatitis C infection.
13. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
14. Subjects who are uncooperative, known to miss appointments and are unlikely to follow medical instructions or are not willing to attend regular visits.
15. Patients with history or a known case of Netherton syndrome.
16. Patients with history or a known case of Cushing syndrome.
17. Patients with lymphadenopathy
18. Participation at another clinical trial within the last 30 days or intend to use other investigational drugs during the course of this study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in the Physicians Global Assessment of Clinical Condition from baseline to week 12 / till complete healing of all baseline lesions of oral lichen planus whichever comes first
baseline to week 12
Secondary Outcome
Outcome
TimePoints
• Change in VAS score from baseline to week 12/ till complete healing of all baseline lesions of oral lichen planus whichever comes first.
• Change from baseline in Patient’s quality of life measured by means of the Oral Health Impact Profile (OHIP - 14).
• Change in the clinical response
baseline to week 12
Target Sample Size
Total Sample Size="154" Sample Size from India="154" Final Enrollment numbers achieved (Total)= "154" Final Enrollment numbers achieved (India)="154"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Lichenplanusisaninflammatorydiseasethatinvolvesskinandmucosa. Itisoneofthe
most common oral diseases that manifests itself in the oral cavity. The
exact cause is unknown,but the immunologic system plays a leading role in the pathogenesis. It is well documented that oral lichen planus (OLP)
represents a cell-mediated immune response with infiltrating cell
population composed of both T4 and T8 lymphocytes. It is a single-arm, 12
weeks active treatment, Efficacy and Safety Evaluation Study. The aim of this study is to evaluate efficacy, safety and tolerability
of topical lipid based tacrolimus ointment 0.1% in patients with
symptomatic oral lichen planus.
Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces
tsukubaensis. It is for topical dermatologic use only. Total
154 patients will be recruited in the study. It consists of three
phases: a screening phase of 2 weeks till the start of the study
drug application over LP lesions, a treatment phase of 12 weeks or till complete
healing of all baseline lesions (confirmed by the Investigator on a scheduled visit) whichever
comes first and safety assessment phase (telephonic). A photographic
evidence of target lesions will be captured in all the study visits. Safety will be
assessed throughout the study by AE reporting, laboratory testing
(hematology, blood/serum biochemistry and urinalysis on specified
visits), physical examination and vital signs