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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit [ Time Frame: Second follow-up visit (Day 5-28) ]

Original Primary Outcome: Treatment status (success/failure) based on Physician's Global Assessment (PGA) of CD at second follow-up, end of treatment visit, i.e., +/- 3 days of the end of treatment. [ Time Frame: Baseline to End of Treatment (6-13 Days) ]

Current Secondary Outcome:

• Treatment Status (Success/Failure) of CD at the First Follow-up Visit [ Time Frame: First follow-up visit (between Day 6 to 10 after start of treatment) ]
  The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. "Success" was defined as a score of 0 or 1 and "failure" was defined as a score of 2, 3, or 4.
• Treatment Status (Success/Failure) of CD at the Third Follow-up Visit [ Time Frame: Third follow-up visit (between Day 6 to 10 after EOT) ]
  The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. "Success" was defined as a score of 0 or 1 and "failure" was defined as a score of 2, 3, or 4.
• Treatment Status (Success/Failure) of CD at the Final Follow-up Visit [ Time Frame: Final follow-up visit (between Day 25 to 35 after EOT) ]
  The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. "Success" was defined as a score of 0 or 1 and "failure" was defined as a score of 2, 3, or 4.
• Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits [ Time Frame: 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) ]
  Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions.
• Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits [ Time Frame: 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) ]
  Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus.
• Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits [ Time Frame: 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) ]
  Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 - 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred).

Original Secondary Outcome:

• Treatment status (success/failure) based on Physician's Global Assessment (PGA) of CD at first, third and final follow up evaluations [ Time Frame: Baseline to final follow up (approx 45 Days) ]
• Patient-rated clinical severity score of lesions at first, second, third and final follow-up evaluations [ Time Frame: Baseline to final follow up (approx 45 Days) ]
• Patient-rated pruritus score at first, second, third and final follow-up evaluations [ Time Frame: Baseline to final follow up (approx 45 Days) ]
• Investigator-rated total signs and symptoms of CD score at first, second, third and final follow-up. visits. The total score is the sum of the individual scores on Pruritus, Erythema, Induration, Vesiculation and Edema. [ Time Frame: Baseline to final follow up (approx 45 Days) ]
• Adverse events [ Time Frame: Baseline to final follow up (approx 45 Days) ]

Dates:
Date Received: June 29, 2009
Date Started: September 2009
Date Completion:
Last Updated: November 21, 2011
Last Verified: November 2011