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
Study Type
OBSERVATIONAL
Enrollment
80
Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Mumbai, Maharashtra, India
Pfizer Investigational Site
Mumbai, Maharashtra, India
Pfizer Investigational Site
Ludhiana, Punjab, India
Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
The signs and symptoms of CD were rated on Physician's Global Assessment (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.
Time frame: Second follow-up visit (Day 5-28)
Treatment Status (Success/Failure) of CD at the First Follow-up Visit
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.
Time frame: First follow-up visit (between Day 6 to 10 after start of treatment)
Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
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.
Time frame: Third follow-up visit (between Day 6 to 10 after EOT)
Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Final follow-up visit (between Day 25 to 35 after EOT)
Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
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.
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)
Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
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.
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)
Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
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).
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)