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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00929981
• Collaborator: (none)
• Enrollment: 80
• Locations: 4
• Duration (Months): 12
• Patients Per Site: 20
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Contact	Drug: Tablet Methylprednisolone (4 or 16 mg)

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Oral Methylprednisolone	Drug: Tablet Methylprednisolone (4 or 16 mg); Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bangalore	Karnataka	India	560 038
2	Pfizer Investigational Site	Mumbai	Maharashtra	India	400 058
3	Pfizer Investigational Site	Mumbai	Maharashtra	India	421 201
4	Pfizer Investigational Site	Ludhiana	Punjab	India	141001

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00929981
• Other Study ID Numbers: B0121004
• First Posted: Jun 30, 2009
• Last Update Posted: Jan 2, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Pfizer: Contact Dermatitis; Allergic Dermatitis
• Additional relevant MeSH terms: Dermatitis; Dermatitis, Contact; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	Medrol
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

Baseline Characteristics

Arm/Group Title	Medrol
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 Participants	80
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	41.2 (12.9)
Sex: Female, Male (Count of Participants)
Female	41 51.3%
Male	39 48.8%

Outcome Measures

1. Primary Outcome

Title	Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
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)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Medrol
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.
Measure Participants	80
Success	93.8 117.3%
Failure	6.30 7.9%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Medrol
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.
Measure Participants	80
Success	52.50 65.6%
Failure	47.50 59.4%

3. Secondary Outcome

Title	Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
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)

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Medrol
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.
Measure Participants	80
Success	100.00 125%
Failure	0 0%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Medrol
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.
Measure Participants	80
Success	100.00 125%
Failure	0 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
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)

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Medrol
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.
Measure Participants	80
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
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)

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Medrol
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.
Measure Participants	80
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
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)

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study medication.

Arm/Group Title	Medrol
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.
Measure Participants	78
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)

Adverse Events

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
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Medrol
	Affected / at Risk (%)	# Events
Total	0/80 (0%)
Other (Not Including Serious) Adverse Events
	Medrol
	Affected / at Risk (%)	# Events
Total	1/80 (1.3%)
Skin and subcutaneous tissue disorders
Dermatitis	1/80 (1.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.