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

NCT00929981 | Completed Results

• 1 other identifier: B0121004
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 4

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

Conditions

Dermatitis, Contact

Keywords

Contact Dermatitis; Allergic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Second follow-up visit (Day 5-28)

Secondary Outcomes (6)

• Treatment Status (Success/Failure) of CD at the First Follow-up Visit

  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

  Third follow-up visit (between Day 6 to 10 after EOT)

• Treatment Status (Success/Failure) of CD at the Final Follow-up Visit

  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

  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

  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)

Study Arms (1)

Oral Methylprednisolone

Drug: Tablet Methylprednisolone (4 or 16 mg)

Interventions

Tablet Methylprednisolone (4 or 16 mg) DRUG

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

Oral Methylprednisolone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Bangalore, Karnataka, 560 038, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 058, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 421 201, India

Location

Pfizer Investigational Site

Ludhiana, Punjab, 141001, India

Location

MeSH Terms

Conditions

Dermatitis, Contact; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 2, 2019
• Results First Posted: December 26, 2011

Record last verified: 2018-12

Locations

IN (4)