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

Condition(s) targeted: Dermatitis, Contact

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

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit

Secondary outcome:

Treatment Status (Success/Failure) of CD at the First Follow-up Visit

Treatment Status (Success/Failure) of CD at the Third Follow-up Visit

Treatment Status (Success/Failure) of CD at the Final Follow-up Visit

Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits

Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits

Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Bangalore, Karnataka 560 038, India

Pfizer Investigational Site, Mumbai, Maharashtra 400 058, India

Pfizer Investigational Site, Mumbai, Maharashtra 421 201, India

Pfizer Investigational Site, Ludhiana, Punjab 141001, India

To obtain contact information for a study center near you, click here.

Starting date: September 2009
Last updated: November 21, 2011