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Is use of combination of Acitretin capsule and topical triamcinolone gel better than triamcinolone gel alone in treatment of lichen planus of mouth.

A placebo controlled double blinded randomized controlled trial comparing the combination of oral acitretin and topical steroids with topical steroid monotherapy in symptomatic oral lichen planus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016448
Enrollment
64
Registered
2018-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K121- Other forms of stomatitis

Interventions

Intervention1: Group 1: Patients will be treated with acitretin in a dose of 25 mg daily in case of body weight 60 kg or less, or 35 mg daily in case of body weight more than 60 kg . Topical tr

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic oral lichen planus. 2. Age - 18 years or more

Exclusion criteria

Exclusion criteria: 1. Any active treatment for oral lichen planus (OLP) in preceding 4 weeks. 2. Presence of any contraindications for acitretin use such as a. pregnant and lactating women. b. leucopenia with leucocyte count c. liver enzymes >2 times the upper limit of reference range d. Moderate to severe cholesterol and triglycerides elevation e. Deranged renal function test 3. Females of reproductive age group who have not completed their family or are not willing to use contraception as required. 4. Patients on any other immunosuppressive, immunomodulatory drugs or on drugs that has significant interaction with acitretin. 5. Dental filling with oral lichenoid reaction. 6. Patients who are unable to attend proposed regular follow-up visits.

Design outcomes

Primary

MeasureTime frame
1. Percentage of patients achieving greater than 75 % reduction (excellent response) in severity score at release from treatment and at the end of 8 weeks post release from treatment, as compared to baseline.Timepoint: 36 weeks—

Secondary

MeasureTime frame
Percentage and absolute reduction in severity score and VAS at release from treatment and at the end of 8 weeks post release from treatment, as compared to baseline in both groups. 2. Percentage of patients achieving good, moderate or poor response based on reduction in severity scores at release from treatment and at the end of 8 weeks post release from treatment. Timepoint: 36 weeks—

Countries

India

Contacts

Public ContactDr Keshavamurthy Vinay

PGIMER (Postgraduate Institute of Medical Education and Research)

vinay.keshavmurthy@gmail.com8872993222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026