Trial Outcomes & Findings for A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients (NCT NCT00929981)
NCT ID: NCT00929981
Last Updated: 2019-01-02
Results Overview
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.
COMPLETED
80 participants
Second follow-up visit (Day 5-28)
2019-01-02
Participant Flow
Participant milestones
| Measure |
Medrol
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients
Baseline characteristics by cohort
| Measure |
Medrol
n=80 Participants
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Age, Continuous
|
41.2 Years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Second follow-up visit (Day 5-28)Population: Full analysis set (FAS) population included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Medrol
n=80 Participants
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
Success
|
93.8 Percentage of Participants
Interval 86.01 to 97.94
|
|
Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
Failure
|
6.30 Percentage of Participants
Interval 2.06 to 13.99
|
SECONDARY outcome
Timeframe: First follow-up visit (between Day 6 to 10 after start of treatment)Population: FAS population included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Medrol
n=80 Participants
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Treatment Status (Success/Failure) of CD at the First Follow-up Visit
Success
|
52.50 Percentage of Participants
Interval 41.02 to 63.79
|
|
Treatment Status (Success/Failure) of CD at the First Follow-up Visit
Failure
|
47.50 Percentage of Participants
Interval 36.21 to 58.98
|
SECONDARY outcome
Timeframe: Third follow-up visit (between Day 6 to 10 after EOT)Population: FAS population included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Medrol
n=80 Participants
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
Success
|
100.00 Percentage of Participants
Interval 95.49 to 100.0
|
|
Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
Failure
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Final follow-up visit (between Day 25 to 35 after EOT)Population: FAS population included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Medrol
n=80 Participants
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
Success
|
100.00 Percentage of Participants
Interval 95.49 to 100.0
|
|
Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
Failure
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 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)Population: FAS population included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Medrol
n=80 Participants
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
Change at second follow-up
|
-6.2 Units on a scale
Standard Deviation 2.09
|
|
Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
Change at third follow-up
|
-6.7 Units on a scale
Standard Deviation 1.68
|
|
Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
Change at final follow-up
|
-6.8 Units on a scale
Standard Deviation 1.60
|
|
Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
Baseline
|
6.8 Units on a scale
Standard Deviation 1.62
|
|
Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
Change at first follow-up
|
-4.1 Units on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: 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)Population: FAS population included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Medrol
n=80 Participants
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
Baseline
|
7.3 Units on a scale
Standard Deviation 1.49
|
|
Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
Change at first follow-up
|
-4.2 Units on a scale
Standard Deviation 2.15
|
|
Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
Change at second follow-up
|
-6.3 Units on a scale
Standard Deviation 2.32
|
|
Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
Change at third follow-up
|
-7.1 Units on a scale
Standard Deviation 1.60
|
|
Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
Change at final follow-up
|
-7.2 Units on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: 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)Population: FAS population included all participants who received at least 1 dose of study medication.
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).
Outcome measures
| Measure |
Medrol
n=78 Participants
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
Baseline
|
9.2 Units on a scale
Standard Deviation 2.64
|
|
Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
Change at first follow-up
|
-5.6 Units on a scale
Standard Deviation 2.56
|
|
Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
Change at final follow-up
|
-9.1 Units on a scale
Standard Deviation 2.69
|
|
Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
Change at second follow-up
|
-8.3 Units on a scale
Standard Deviation 3.11
|
|
Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
Change at third follow-up
|
-9.0 Units on a scale
Standard Deviation 2.72
|
Adverse Events
Medrol
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medrol
n=80 participants at risk
Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
1/80
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER