N/A
N=80
A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients
Dermatitis, Contact
Bottom Line
View on ClinicalTrials.gov: NCT00929981 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit — 93.8; 6.30 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tablet Methylprednisolone (4 or 16 mg) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit |
93.8; 6.30 | — |
| SECONDARY Treatment Status (Success/Failure) of CD at the First Follow-up Visit |
52.50; 47.50 | — |
| SECONDARY Treatment Status (Success/Failure) of CD at the Third Follow-up Visit |
100.00; 0 | — |
| SECONDARY Treatment Status (Success/Failure) of CD at the Final Follow-up Visit |
100.00; 0 | — |
| SECONDARY Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits |
6.8; -4.1; -6.2; -6.7; -6.8 | — |
| SECONDARY Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits |
7.3; -4.2; -6.3; -7.1; -7.2 | — |
| SECONDARY Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits |
9.2; -5.6; -8.3; -9.0; -9.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00929981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.