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

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ClinicalTrials.gov Identifier: NCT00929981
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : December 26, 2011
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Dermatitis, Contact
Intervention Drug: Tablet Methylprednisolone (4 or 16 mg)
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medrol
Hide Arm/Group Description Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Period Title: Overall Study
Started 80
Completed 80
Not Completed 0
Arm/Group Title Medrol
Hide Arm/Group Description Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
41.2  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
41
  51.2%
Male
39
  48.8%
1.Primary Outcome
Title Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all participants who received at least 1 dose of study medication.
Arm/Group Title Medrol
Hide Arm/Group Description:
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Success
93.8
(86.01 to 97.94)
Failure
6.30
(2.06 to 13.99)
2.Secondary Outcome
Title Treatment Status (Success/Failure) of CD at the First Follow-up Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least 1 dose of study medication.
Arm/Group Title Medrol
Hide Arm/Group Description:
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Success
52.50
(41.02 to 63.79)
Failure
47.50
(36.21 to 58.98)
3.Secondary Outcome
Title Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least 1 dose of study medication.
Arm/Group Title Medrol
Hide Arm/Group Description:
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Success
100.00
(95.49 to 100.00)
Failure
0
(0 to 0)
4.Secondary Outcome
Title Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
Hide Description 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 Final follow-up visit (between Day 25 to 35 after EOT)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least 1 dose of study medication.
Arm/Group Title Medrol
Hide Arm/Group Description:
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Success
100.00
(95.49 to 100.00)
Failure
0
(0 to 0)
5.Secondary Outcome
Title Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least 1 dose of study medication.
Arm/Group Title Medrol
Hide Arm/Group Description:
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 6.8  (1.62)
Change at first follow-up -4.1  (1.86)
Change at second follow-up -6.2  (2.09)
Change at third follow-up -6.7  (1.68)
Change at final follow-up -6.8  (1.60)
6.Secondary Outcome
Title Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least 1 dose of study medication.
Arm/Group Title Medrol
Hide Arm/Group Description:
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 7.3  (1.49)
Change at first follow-up -4.2  (2.15)
Change at second follow-up -6.3  (2.32)
Change at third follow-up -7.1  (1.60)
Change at final follow-up -7.2  (1.47)
7.Secondary Outcome
Title Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who received at least 1 dose of study medication.
Arm/Group Title Medrol
Hide Arm/Group Description:
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 9.2  (2.64)
Change at first follow-up -5.6  (2.56)
Change at second follow-up -8.3  (3.11)
Change at third follow-up -9.0  (2.72)
Change at final follow-up -9.1  (2.69)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Medrol
Hide Arm/Group Description Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
All-Cause Mortality
Medrol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Medrol
Affected / at Risk (%)
Total   0/80 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medrol
Affected / at Risk (%)
Total   1/80 (1.25%) 
Skin and subcutaneous tissue disorders   
Dermatitis * 1  1/80 (1.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, medDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00929981     History of Changes
Other Study ID Numbers: B0121004
First Submitted: June 29, 2009
First Posted: June 30, 2009
Results First Submitted: August 3, 2011
Results First Posted: December 26, 2011
Last Update Posted: January 1, 2019