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Study of safety and efficacy profile of systemic corticosteroids (prednisolone tablets) and isotretinoin tablets versus systemic corticosteroids (prednisolone tablets) alone in cutaneous lichen planus (violet colored itchy elevated lesions over body)-

Safety and efficacy profile of systemic corticosteroids and isotretinoin versus systemic corticosteroids alone in cutaneous lichen planus- A hospital based prospective double blind placebo controlled comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010292
Enrollment
60
Registered
2017-10-31
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: null- Cutaneous lichen planus

Interventions

Intervention1: Oral prednisolone: 0.15 mg/kg/day to 0.5 mg/kg/day daily for 8 weeks Intervention2: Oral isotretinoin: 10 mg/day to 20 mg/day daily for 8 weeks Control Intervention1: Cutaneous lichen p

Sponsors

Krishna Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A.Must give written consent before any treatment commenced. B.Must be diagnosed to be suffering from cutaneous lichen planus either by clinical examination or histopathology if required. C.Must have generalised lichen planus involving minimum 20% body surface area or cases of palmoplantar lichen planus D.Must stop any other modality of treatment, two months prior to the inclusion in study. E.Must be able and willing, in the view of investigator, to comply all study procedure.

Exclusion criteria

Exclusion criteria: A. Patient having only oral lichen planus, genital lichen planus, nail lichen planus, follicular lichen planus, actinic lichen planus, lichen planus pigmentosus, lichen planus pemphigoides, B. Patient with hypersensitivity to drug or patient intolerant to the study medication. C. Pregnant and lactating patient. D. Patient with unrealistic expectations. E. Not willing for regular follow up. F. Patient with clinically significant cardiovascular, haematological, pancreatic, metabolic neurological or any other laboratory anomaly, which in the judgement of investigator, would interfere in participation in study or proper evaluation. G. Patient on any other systemic drugs therapy which in the judgement of investigator may interfere with interpretation of results. H. Patient having history of tuberculosis or chest X-ray showing evidence of any infective pathology. I. Immunocompromised patients

Design outcomes

Primary

MeasureTime frame
1.) Body surface area 2.) Lichen planus severity indexTimepoint: 56 days

Secondary

MeasureTime frame
Physician global assessmentTimepoint: 56 days;Visual analogue scaleTimepoint: 56 days

Countries

India

Contacts

Public ContactHarsimran Kaur

Krishna Institute of Medical Sciences

jamalevarsha@gmail.com9822572887

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026