Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oral Methylprednisolone
干预措施: Tablet Methylprednisolone (4 or 16 mg) (Drug)
结局指标
主要结局
Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
时间窗: 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.
次要结局
- Treatment Status (Success/Failure) of CD at the Third Follow-up Visit(Third follow-up visit (between Day 6 to 10 after EOT))
- 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))
- Treatment Status (Success/Failure) of CD at the Final Follow-up Visit(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(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(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(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))