A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients

Pfizer

Status: Completed

Conditions: Dermatitis, Contact

Treatments: Drug: Tablet Methylprednisolone (4 or 16 mg)

Study type: Observational

Funder types: Industry

Identifiers

NCT00929981

B0121004

Details and patient eligibility

About

This study will be a prospective, non-interventional, single arm and open label study, in patients with contact dermatitis requiring systemic steroid therapy with a purpose to obtain the real life effectiveness and tolerability of Medrol in treating contact dermatitis in Indian patients. Patients with contact dermatitis who have been prescribed for Medrol will be enrolled into the study and will be followed up for the resolution of symptoms

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• To be eligible for enrollment in this study, patients must be prescribed oral Medrol tablets (4mg and 16 mg) for contact dermatitis as per the locally approved prescribing information
• Medrol tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol tablet will necessarily precede and will be independent of the decision to enroll patient into the study
• Only those patients, who are ready to sign an informed consent, will be included in the study
• Subject can be contacted through telephone

Exclusion criteria

• Patients who have any other dermatological or systemic condition that may interfere or confound with the study outcome measurements
• Patients taking any oral steroid preparation or immunomodulators or have taken any such oral medication during last 15 days before enrollment. NSAIDs (Non Steroidal Anti-Inflammatory Agents) are excluded from the list
• Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
• Participation in other studies within last 1 month before the current study begins and/or during study participation
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

Trial design

80 participants in 1 patient group

Oral Methylprednisolone

Treatment:

Drug: Tablet Methylprednisolone (4 or 16 mg)