An open label, phase II study To Evaluate The Safety And Efficacy of Eczero® cream in subjects with Mild to Moderate Eczema.Protocol ID : IHS/PEL/01/14
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 1.Reduction in the severity of symptoms of Mild to moderate eczema: Erythema, excoriation ; edema/papulation, oozing/crusts lichenification, local pruritus with local SCORAD Index (Screening /Baseline, Day 7,Day 14, Day 21 and Day 28.
研究概览
简要总结
To Evaluate e the safety and efficacy of efficacy of Eczero® cream in patients suffering from mild to moderate eczema.
An Open Label, non-comparative, Phase II, clinical trial was conducted at two sites. The treatment was given for a period of 28 days. The primary outcome measure in this trial was assessment of reduction in severity of mild to moderate Eczema symptoms using local SCORAD index in each visit. Overall eczema severity recorded by EASI index during the screening/baseline visit and on day 28. The reduction in the severity of Eczema by local SCORAD score, VAS Score for itching, reduction in lesion and inflammation was assessed on day 1, day 7, day 14, day 21 and Day 28 of the Trial.
Eczero cream is an plant based cream developed after thorough research in pre-clinical models showing efficacy for eczema. the cream had potent anti-bacterial and anti-inflammatory activity.
Results:
The primary efficacyparameter total SCORAD score showed significant reduction as compared to thebaseline visit associated F value, and p value [F (5, 38) = 7.12, p = 0.0002]. The severity of diseasewas quantitatively calculated by a local SCORAD index consisting of theattributes like edema, erythema, excoriation, lichenification, pruritus andoozing measured on 0-3 scale. Application of Eczero cream showed significantreduction in edema [F (5, 38)= 9.68, p =. <.0001], erythema[F (5, 38) = 9.42, p = <0.0001], lichenification [F (5, 38) = 7.93, p =<0.0001], and oozing [F (5, 38) = 4.16, p = 0.0041] whereas the symptoms likeexcoriation [F (5, 38) = 1.98, p= 0.1039] and pruritus [F (5, 38)= 1.76, p = .0.1456] doesnot showed significant outcome. However, the VAS score was assessed to evaluatethe pruritus as the immediate complaint of eczema showed significant reductionof pruritus [F (5, 38) = 9.68, p= <0.0001]. Total of 5 adverse events were noted in 4 subjects,i.e pruritus, diarrhea, constipation, cough and cold. Out of the 5 adverseevents; pruritus may have a probable causal relation with application.
Physician’ globalassessment of therapy with photographs of lesion were recorded onBaseline/screening (week 1) and on last follow-up visit in Week 4 to assess theoverall improvement in the lesion.
The image was analyzedbased on the Physician’ Global Assessment; where the severity was assessed on afive point scale along with PhGA, as Worse = 1 (Exacerbation of disease),Little = 2 (Less than 25% improvement), Fair 3 = (Between 25 and 50%improvement), Good = 4 (Between 50 and 75% improvement) and Excellent = 5 (Atleast 75% improvement).
Almost 22.5% (9) patients’ showed an excellent resultsbased on photographic assessment combine with PhGA; whereas 45% (18) patientsreceived good results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult males and females ≥18 years and less than 75 years of age.
- •2.Patients having chronic eczema (suffering from eczema from the past 1 year) with an EASI score in the range of 7-
- •(Both inclusive).
- •3.Patient not having any systemic immunosuppressive therapy(eg steroids) 4.Female, not currently pregnant or breast feeding and are using mechanical contraceptive devices such as Intra-uterine devices (IUD).
- •5.Stable, adequately treated medical conditions other than eczema (such as stable blood pressure, stable hypertension, hyperlipidemia & uncomplicated osteoarthritis).
- •6.Subjects who are able and willing to give written informed consent.
排除标准
- •1.Patients having history of Medical conditions such as Diabetes mellitus, Thyroiditis, Rheumatoid arthritis, Multiple sclerosis, Uveitis, Glomerulonephritis, Helminthic, uncontrolled hypertension, severe cardiovascular, pulmonary, (especially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease.
- •2.Patient having abnormal values above or below ±20% of the normal value range as mentioned in the protocol.
- •3.Females using oral contraceptives.
- •4.History of any topical or herbal drug hyper sensitivity.
- •5.History of alcoholism& drug abuse.
- •6.Significant infection such as influenza, acute gastrointestinal symptoms e.g. nausea, vomiting, diarrhea, heartburn) at the time of screening and/or admission.
- •7.Subjects who have used any investigational drug and /or participated in any clinical trial.
- •8.Subjects currently receiving drugs like Lithium, B- blockers, Antimalarial and NSAIDs. 9.Subjects receiving any Ayurvedic, Homeopathic or Herbal drug, medicated oils or Creams; medicated shampoos, hair colouring, perms, hair chemical treatments; continuously for one month, three months prior to screening visit.
- •10.Target lesions associated with secondary infections.
结局指标
主要结局
1.Reduction in the severity of symptoms of Mild to moderate eczema: Erythema, excoriation ; edema/papulation, oozing/crusts lichenification, local pruritus with local SCORAD Index (Screening /Baseline, Day 7,Day 14, Day 21 and Day 28.
时间窗: Day 7,Day 14, Day 21 and Day 28.
次要结局
- 1.Reduction in inflammation (Screening/baseline, Day 28)(2.Reduction in lesion by Photographic assessment ( Screening /baseline, Day 28))