Clinical trial NCT00929981: A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients
Official title: Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis, Contact
Keywords: Contact Dermatitis
Allergic Dermatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been prescribed oral Medrol Tablets (4 or 16 mg) for treatment of contact dermatitis will be enrolled

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
timeFrame: Second follow-up visit (Day 5-28)
Secondary outcomes:
measure: Treatment Status (Success/Failure) of CD at the First Follow-up Visit
timeFrame: First follow-up visit (between Day 6 to 10 after start of treatment)
measure: Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
timeFrame: Third follow-up visit (between Day 6 to 10 after EOT)
measure: Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
timeFrame: Final follow-up visit (between Day 25 to 35 after EOT)
measure: Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
timeFrame: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)
measure: Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
timeFrame: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)
measure: Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
timeFrame: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: