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

Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00929981

Enrollment

Registered

2009-06-30

Start date

2009-09-30

Completion date

2010-09-30

Last updated

2019-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Contact

Keywords

Contact Dermatitis, Allergic Dermatitis

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

Interventions

DRUGTablet Methylprednisolone (4 or 16 mg)

Oral Methylprednisolone tablets (4mg, 16mg) will be given as per locally approved prescribing information

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.
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).
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.

Countries

India

Participant flow

Participants by arm

Arm	Count
Medrol Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.	80
Total	80

Baseline characteristics

Characteristic	Medrol
Age, Continuous	41.2 Years STANDARD_DEVIATION 12.9
Sex: Female, Male Female	41 Participants
Sex: Female, Male Male	39 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	1 / 80
serious Total, serious adverse events	0 / 80

Outcome results

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
Medrol	Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit	Success	93.8 Percentage of Participants
Medrol	Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit	Failure	6.30 Percentage of Participants

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).

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)