Trial · NCT00929981
A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients
NCT00929981, Completed, Pfizer; results first posted 2011-12-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients. Trials, record NCT00929981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00929981
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients
- NCT number
- NCT00929981
- Status
- Completed
- Enrollment
- 80 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Dermatitis, Contact
- Interventions
- Tablet Methylprednisolone (4 or 16 mg)
- First posted
- 2009-06-30
- Last updated
- 2019-01-02
- Results first posted
- 2011-12-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit | Second follow-up visit (Day 5-28) | 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 | 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) | 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. |
| Secondary | Treatment Status (Success/Failure) of CD at the Third Follow-up Visit | Third follow-up visit (between Day 6 to 10 after EOT) | 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. |
| Secondary | Treatment Status (Success/Failure) of CD at the Final Follow-up Visit | Final follow-up visit (between Day 25 to 35 after EOT) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | Change From Baseline in Investigator-rated Total Signs and Symptoms of CD 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) | 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). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit | Second follow-up visit (Day 5-28) | Full analysis set (FAS) population included all participants who received at least 1 dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | 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) | FAS population included all participants who received at least 1 dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Status (Success/Failure) of CD at the Third Follow-up Visit | Third follow-up visit (between Day 6 to 10 after EOT) | FAS population included all participants who received at least 1 dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Status (Success/Failure) of CD at the Final Follow-up Visit | Final follow-up visit (between Day 25 to 35 after EOT) | FAS population included all participants who received at least 1 dose of study medication. | Percentage of Participants | NUMBER |
| SECONDARY | 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) | FAS population included all participants who received at least 1 dose of study medication. | Units on a scale | MEAN |
| SECONDARY | 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) | FAS population included all participants who received at least 1 dose of study medication. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Investigator-rated Total Signs and Symptoms of CD 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) | FAS population included all participants who received at least 1 dose of study medication. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit | Medrol | Success | 93.8 | 95% Confidence Interval 86.01 to 97.94 | Percentage of Participants |
| Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit | Medrol | Failure | 6.30 | 95% Confidence Interval 2.06 to 13.99 | Percentage of Participants |
| Treatment Status (Success/Failure) of CD at the First Follow-up Visit | Medrol | Success | 52.50 | 95% Confidence Interval 41.02 to 63.79 | Percentage of Participants |
| Treatment Status (Success/Failure) of CD at the First Follow-up Visit | Medrol | Failure | 47.50 | 95% Confidence Interval 36.21 to 58.98 | Percentage of Participants |
| Treatment Status (Success/Failure) of CD at the Third Follow-up Visit | Medrol | Success | 100.00 | 95% Confidence Interval 95.49 to 100.00 | Percentage of Participants |
| Treatment Status (Success/Failure) of CD at the Third Follow-up Visit | Medrol | Failure | 0 | 95% Confidence Interval 0 to 0 | Percentage of Participants |
| Treatment Status (Success/Failure) of CD at the Final Follow-up Visit | Medrol | Success | 100.00 | 95% Confidence Interval 95.49 to 100.00 | Percentage of Participants |
| Treatment Status (Success/Failure) of CD at the Final Follow-up Visit | Medrol | Failure | 0 | 95% Confidence Interval 0 to 0 | Percentage of Participants |
| Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits | Medrol | Baseline | 6.8 | Standard Deviation 1.62 | Units on a scale |
| Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits | Medrol | Change at first follow-up | -4.1 | Standard Deviation 1.86 | Units on a scale |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Medrol | 80 | |
| Overall Study | COMPLETED | Medrol | 80 | |
| Overall Study | NOT COMPLETED | Medrol | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dermatitis | Skin and subcutaneous tissue disorders | Medrol | 1 | 80 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medrol | ||
| Total, other adverse events | Medrol | 1 | 80 |
| Total, serious adverse events | Medrol | 0 | 80 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00929981
GET https://conductscience.org/api/trials/v1/NCT00929981/results?page=2