A study to evaluate the efficacy, safety and tolerability of tacrolimus ointment 0.1% in patients of oral lichen planus
- Conditions
- Other lichen planus,
- Registration Number
- CTRI/2015/09/006211
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Lichen planus (LP) is a chronic inflammatorymucocutaneous disease that can have both cutaneous and oral involvement affectingthe skin, the tongue, and the oral mucosa. Lichen planus is most commonly foundon 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 itinvolves multiple mucosal surfaces, it becomes more resistant to treatment.Even with the effective treatments, relapses are common. Moreover, patients areunable to tolerate a treatment because of its adverse effects. According to a survey mailed to 40 patientswith symptomatic oral lichen planus treated with topical tacrolimus, mostpatients experienced symptomatic improvement in less than 1 month. Topicaltacrolimus has been reported to be effective for OLP, including those formsthat had been recalcitrant to treatment and disabling. Further, based on thesafety demonstrated in atopic dermatitis trials that included children as youngas age 2 years, topical tacrolimus ointment is apparently a safe, effective,and well-tolerated therapeutic modality. Overall, the lipid based tacrolimusointment approved by the drugs controller general of India for usage in atopicdermatitis is expected to offer a safe and effective therapeutic modality withlong-term benefits for lesions of lichen planus also.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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).
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method •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).
Trial Locations
- Locations (9)
B.J. Medical College & Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Bhagwan Mahaveer Jain Hospital
🇮🇳Bangalore, KARNATAKA, India
Dermatology Medical College
🇮🇳Kolkata, WEST BENGAL, India
Jehangir Clinical Development Centre Pvt.Ltd, Jehangir Hospital Premises
🇮🇳Pune, MAHARASHTRA, India
King George Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Medical College Baroda , Sir Sayajirao General Hospital
🇮🇳Vadodara, GUJARAT, India
Ratandeep Multispeciality Hospital
🇮🇳Ahmadabad, GUJARAT, India
Sheth V. S. General Hospital ,Smt. N. H. L. Municipal Medical College
🇮🇳Ahmadabad, GUJARAT, India
Sri Venkateshwara Hospital
🇮🇳Bangalore, KARNATAKA, India
B.J. Medical College & Civil Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Bela J ShahPrincipal investigator9898059289shah.drbela@gmail.com