| CTRI Number |
CTRI/2015/09/006211 [Registered on: 23/09/2015] Trial Registered Prospectively |
| Last Modified On: |
22/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the efficacy, safety and tolerability of tacrolimus ointment 0.1% in patients of oral lichen planus |
|
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% in patients of oral lichen planus |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 351-12; Version 3.0; Date: 09/06/2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hitesh Maheshwari |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202490 |
| Fax |
07940202021 |
| Email |
hiteshmaheshwari@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Falgun Vyas |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202354 |
| Fax |
07940202021 |
| Email |
falgunvyas@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Hitesh Maheshwari |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202490 |
| Fax |
07940202021 |
| Email |
hiteshmaheshwari@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd., 2nd Floor, Chinubhai
Center, Ashram Road, Ahmedabad 380009,
Gujarat, India
Tel. No.:07926576655
Fax: 07926578862
|
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
Intas Pharmaceuticals Ltd., 2nd Floor, Chinubhai
Center, Ashram Road, Ahmedabad 380009,
Gujarat, India
Tel. No.:07926576655
Fax: 07926578862
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bela J Shah |
B.J. Medical College & Civil Hospital |
Professor and HOD, Department of Dermatology, Room No: 139 , 1st Floor, OPD Builiding, Asarwa-380016
Ahmadabad
GUJARAT |
9898059289
shah.drbela@gmail.com |
| Dr Manoj Kumar H Parekh |
Bhagwan Mahaveer Jain Hospital |
Department of Dermatology, Ground floor, Room no. 8, Bhagwan Mahaveer Jain Hospital, Millers Road, Vasanthnagar- 560052
Bangalore
KARNATAKA |
9845225459
drmanojparekh@gmail.com |
| Dr N K Das |
Dermatology Medical College |
Associate Professor, Department of Dermatology, Room No: 22 , Medical College, 88 College Street-73.
Kolkata
WEST BENGAL |
9433394148
drdasnilay@gmail.com |
| Dr Pradyumna Prakash Vaidya |
Jehangir Clinical Development Centre Pvt.Ltd, Jehangir Hospital Premises |
Department of Dermatology Room# 32, Sassoon Road- 411001
Pune
MAHARASHTRA |
9822400964
drpvaidya@gmail.com |
| Dr K Venkatachalam |
King George Hospital |
Department of Dermatology, 1st Floor, Room no. 32, Maharanipeta-530002
Visakhapatnam
ANDHRA PRADESH |
9848398923
drkvchalam99@yahoo.com |
| Dr Yogesh S Marfatia |
Medical College Baroda , Sir Sayajirao General Hospital |
OPD -01 ,Depatment of Skin ans VD , Room no. 25, Medical College Baroda , Sir Sayajirao General Hospital, Anandpura- 390001
Vadodara
GUJARAT |
9825917442
ym11256@gmail.com |
| Dr Bhavik Bhavsar |
Ratandeep Multispeciality Hospital |
2nd Floor, Dept of Dermatology, Room No: 34, Nakshatra Complex, above HDFC bank, Maninagar cross road-380008 Â
Ahmadabad
GUJARAT |
9825953263
bhavik.bhavsar78@gmail.com |
| Dr Ranjan C Raval |
Sheth V. S. General Hospital ,Smt. N. H. L. Municipal Medical College |
Department of Dermatology, Room no. 9, Sheth V. S. General Hospital ,Smt. N. H. L. Municipal Medical College, Ellisebridge-380006
Ahmadabad
GUJARAT |
9327022606
ranjancraval@gmail.com |
| Dr Leelavathy Budamakuntla |
Sri Venkateshwara Hospital |
Department of Dermatology, Room # 86, Hosur main road, Madiwala-68
Bangalore
KARNATAKA |
9448169982
drleelaskincare@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee, Jahangir Clinical Development Centre, Dr. Pradyumna |
Submittted/Under Review |
| Ethics committee, Ratan Deep Multispecialty Hospital, Dr. Bhavik Bhavsar |
Submittted/Under Review |
| Institutional Ethics Committee on Human Research, Medical College Baroda, Dr Yogesh |
Submittted/Under Review |
| Institutional Ethics Committee Bhagwan Mahaveer Jain Hospital, Dr. Manoj Kumar |
Submittted/Under Review |
| Institutional Ethics Committee for Human Research, Dr.N.K.Das |
Submittted/Under Review |
| Institutional Ethics Committee, Smt. NHL, Municipal Medical College, Dr. Ranjan C Raval |
Submittted/Under Review |
| Instiutional Ethics Committee, King George Hospital, Dr K Venkatachalam |
Approved |
| Instuitutional Ethics Committee B.J Medical College and Civil Hospital, Dr Bela Shah |
Submittted/Under Review |
| Sri Venkateshwara Hospital Ethics Committee, Dr. Leelavathy |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L438||Other lichen planus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lipid based tacrolimus ointment 0.1% |
Dose: 1 cm ribbon spread is recommended, Frequency: Four times in a day, Mode of Administration: Topical, Duration of treatment: 6 weeks / 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
2.Confirmed diagnosis of symptomatic oral lichen planus
3.Symptomatic OLP (Spontaneous or meal related oral pain). |
|
| ExclusionCriteria |
| Details |
1.Asymptomatic lichen planus with no ulcerated or erythematous oral lesions.
2.Who have received systemic immunosuppressants, oral retinoids or any other systemic therapies known or suspected to have an effect on lichen planus within 4 weeks prior to participation in the study.
3.Who have been treated with topical therapy
4.Severe or recurrent systemic or generalized infections (bacterial, viral or fungal).
5.Who have unstable or uncontrolled diabetes or hypertension.
6.Hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin, etc. |
|
|
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 6 / complete healing of all baseline lesions whichever comes first. |
Baseline to week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Patient’s pain experience measured by means of the Visual Analogue Scale (VAS).
•Patient’s quality of life measured by means of the Oral Health Impact Profile (OHIP - 14).
|
Baseline to week 6 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2015 |
| Date of Study Completion (India) |
02/05/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Lichen planus (LP) is a chronic inflammatory
mucocutaneous disease that can have both cutaneous and oral involvement affecting
the skin, the tongue, and the oral mucosa. Lichen planus is most commonly found
on the flexor surfaces of the upper extremities, on the genitalia, the nails,
and the scalp and on the mucous membranes.
At present there is no permanent cure for lichen planus. When it
involves multiple mucosal surfaces, it becomes more resistant to treatment.
Even with the effective treatments, relapses are common. Moreover, patients are
unable to tolerate a treatment because of its adverse effects. According to a survey mailed to 40 patients
with symptomatic oral lichen planus treated with topical tacrolimus, most
patients experienced symptomatic improvement in less than 1 month. Topical
tacrolimus has been reported to be effective for OLP, including those forms
that had been recalcitrant to treatment and disabling. Further, based on the
safety demonstrated in atopic dermatitis trials that included children as young
as age 2 years, topical tacrolimus ointment is apparently a safe, effective,
and well-tolerated therapeutic modality. Overall, the lipid based tacrolimus
ointment approved by the drugs controller general of India for usage in atopic
dermatitis is expected to offer a safe and effective therapeutic modality with
long-term benefits for lesions of lichen planus also. |