Skip to main content
OpenTrials
Completed

NCT Number: NCT00929981

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dermatitis, Contact Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Bangalore, Karnataka, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tablet Methylprednisolone (4 or 16 mg)

Drug

Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information

Primary outcomes

  1. Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit

    Time frame: Second follow-up visit (Day 5-28)

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  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.

  5. 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.

  6. 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).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2009
Registry last updated
Jan 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.