CTRI/2018/01/011211 [Registered on: 09/01/2018] Trial Registered Retrospectively
Last Modified On:
19/11/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Single Arm Study
Public Title of Study
A study To Evaluate The Safety And Efficacy of Eczero® cream in patients with Mild to Moderate Eczema.
Scientific Title of Study
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
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ECZERO/ IHS/PEL/01/14, version No.: 1.0, date: 14th Oct.2015
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Nimesh Mehta
Designation
(MBBS, DV&D, M.D.)
Affiliation
Sai Medi Cnetre, Dermal Division.
Address
Sai Medi Centre, 55 B.D.D Chawl Worli Mumbai 400030
An Open Label, non-comparative, Phase II, clinical trial was conducted at two sites.
An Open Label, non-comparative, Phase II, clinical trial was conducted at two sites.
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
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 7-15. (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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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.
Day 7,Day 14, Day 21 and Day 28.
Secondary Outcome
Outcome
TimePoints
1. Reduction in inflammation (Screening/baseline, Day 28)
2. Reduction in lesion by Photographic assessment ( Screening /baseline, Day 28)
3. Visual Analogue scale score for relief from itching (pruritus) ( Screening /Baseline, Day 7, Day14, Day 21 and Day 28
4. Patients& Physician’ Global Assessment of the Treatment (Screening /Baseline , Day 28)
Day 7, Day 14, Day 21 and Day 28)
Target Sample Size
Total Sample Size="40" Sample Size from India="40" Final Enrollment numbers achieved (Total)= "40" Final Enrollment numbers achieved (India)="40"
Phase of Trial
Phase 2
Date of First Enrollment (India)
31/12/2014
Date of Study Completion (India)
10/08/2015
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="7" Days="10"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
None yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
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 efficacy
parameter total SCORAD score showed significant reduction as compared to the
baseline visit associated F value, and p value [F (5, 38) = 7.12, p = 0.0002]. The severity of disease
was quantitatively calculated by a local SCORAD index consisting of the
attributes like edema, erythema, excoriation, lichenification, pruritus and
oozing measured on 0-3 scale. Application of Eczero cream showed significant
reduction 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 like
excoriation [F (5, 38) = 1.98, p
= 0.1039] and pruritus [F (5, 38)
= 1.76, p = .0.1456] does
not showed significant outcome. However, the VAS score was assessed to evaluate
the pruritus as the immediate complaint of eczema showed significant reduction
of 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 adverse
events; pruritus may have a probable causal relation with application.
Physician’ global
assessment of therapy with photographs of lesion were recorded on
Baseline/screening (week 1) and on last follow-up visit in Week 4 to assess the
overall improvement in the lesion.
The image was analyzed
based on the Physician’ Global Assessment; where the severity was assessed on a
five 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 (At
least 75% improvement).
Almost 22.5% (9) patients’ showed an excellent results
based on photographic assessment combine with PhGA; whereas 45% (18) patients
received good results.