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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00929981
First received: June 29, 2009
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention
Dermatitis, Contact
 Drug: Tablet Methylprednisolone (4 or 16 mg)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit [ Time Frame: Second follow-up visit (Day 5-28) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 80
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral Methylprednisolone Drug: Tablet Methylprednisolone (4 or 16 mg)
Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929981

Locations
India
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 038
Pfizer Investigational Site
Mumbai, Maharashtra, India, 421 201
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 058
Pfizer Investigational Site
Ludhiana, Punjab, India, 141001
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00929981     History of Changes
Other Study ID Numbers: B0121004
Study First Received: June 29, 2009
Results First Received: August 3, 2011
Last Updated: November 21, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by Pfizer:
Contact Dermatitis
Allergic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 17, 2013