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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Methylprednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablet Methylprednisolone (4 or 16 mg) | Drug | Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Status (Success/Failure) of CD at the First Follow-up Visit | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been prescribed oral Medrol Tablets (4 or 16 mg) for treatment of contact dermatitis will be enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Bangalore | Karnataka | 560 038 | India | ||
| Pfizer Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medrol | Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medrol | Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set (FAS) population included all participants who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Second follow-up visit (Day 5-28) |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medrol | Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis | Skin and subcutaneous tissue disorders | medDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| 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 | 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. | Third follow-up visit (between Day 6 to 10 after EOT) |
| Treatment Status (Success/Failure) of CD at the Final Follow-up Visit | 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. | 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 | 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. | 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 | 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. | 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 Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits | 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). | 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) |
| Mumbai |
| Maharashtra |
| 400 058 |
| India |
| Pfizer Investigational Site | Mumbai | Maharashtra | 421 201 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141001 | India |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Treatment Status (Success/Failure) of CD at the First Follow-up Visit | 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. | FAS population included all participants who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | Percentage of Participants | First follow-up visit (between Day 6 to 10 after start of treatment) |
|
|
|
| Secondary | Treatment Status (Success/Failure) of CD at the Third Follow-up Visit | 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. | FAS population included all participants who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Third follow-up visit (between Day 6 to 10 after EOT) |
|
|
|
| Secondary | Treatment Status (Success/Failure) of CD at the Final Follow-up Visit | 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. | FAS population included all participants who received at least 1 dose of study medication. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Final follow-up visit (between Day 25 to 35 after EOT) |
|
|
|
| Secondary | Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits | 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. | FAS population included all participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a scale | 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) |
|
|
|
| Secondary | Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits | 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. | FAS population included all participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a scale | 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) |
|
|
|
| Secondary | Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits | 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). | FAS population included all participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a scale | 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) |
|
|
|
| 0 |
| 80 |
| 1 |
| 80 |
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.
| D012873 |
| Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Change at third follow-up |
|
| Change at final follow-up |
|
| Title | Measurements |
|---|---|
|
| Change at third follow-up |
|
| Change at final follow-up |
|
| Title | Measurements |
|---|---|
|
| Change at third follow-up |
|
| Change at final follow-up |
|