| CTRI Number |
CTRI/2021/03/032149 [Registered on: 19/03/2021] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [safety and efficacy] |
| Study Design |
Other |
|
Public Title of Study
|
Safety and Efficacy of Body Lotion and Body Wash in Adult Female Subjects with Mild To Moderate Eczema. |
|
Scientific Title of Study
|
An Open-label, Single Centre Study, to Determine the Safety and Efficacy of Body Lotion and Body Wash in Adult Female Subjects with Mild To Moderate Eczema. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00741, Ver#01, Dated 02 Mar 21 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Phone 91 79 68221100
Fax 91 79 66219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
07966219549 |
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Phone 91 79 68221100
Fax 91 79 66219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
07966219549 |
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Simran Sethi |
| Designation |
Director Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Phone 91 79 68221100
Fax 91 79 66219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
07966219549 |
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Wipro Manufacturing Services Sdn Bhd |
| Address |
Wipro Manufacturing Services Sdn. Bhd.
No. 7 Persiaran Subang Permai,
Taman Perindustrian Subang
47610 Selangor Darul Ehsan,
Malaysia.
Phone: (603) 56315588
Fax: (603) 56311778
|
| Type of Sponsor |
Other [Personal Care Industry] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not Applicable
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Joshi |
Cliantha Research |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Phone 91 79 68221100
Fax 91 79 66219549
Ahmadabad
GUJARAT |
8000085049
07966219549
pjoshi@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L208||Other atopic dermatitis. Ayurveda Condition: Not Applicable, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Body Lotion |
Subjects will be instructed to apply peaâ€sized amount of test product twice a day for each eczema site on their body to moisturize the test skin site |
| Intervention |
Body Wash |
Subjects will be instructed to use body wash externally. Wet body, apply the 4 to 5 pumps (approximately 5 g) amount of Body Wash. Lather and rinse well. Use Once Daily for 28 consecutive days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Age: 18 to 65 years (both inclusive) old healthy, non-pregnant, and non-lactating female at the time of consent.
2. Females who have childbearing potential should have a negative urine pregnancy test at the time of the screening visit.
3. Mild to Moderate Eczema determined by Eczema Area and Severity Index (EASI) score on screening visit. [Subjects with moderate erythema (Redness: score 2) and mild scratch mark (Scratching: score 1) will be enrolled in the study].
4. Subjects with at least two active lesions on feet/face/hands or any part of the body.
5. Subjects have only a few or no pigmentation on the selected test site.
6. The subject’s in general good health as determined by Investigator based on medical history.
7. Subjects must agree to refrain from shower/bath or generally wet their skin within 3 hours before scheduled study visits.
8. Subjects must agree to wear loose clothing to allow easy exposure to the entire body during study visits.
9. Subjects must be able to understand and provide written informed consent to participate in the study.
10. Subjects should be willing and able to follow the study protocol to participate in the study.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Selection of unaffected and affected test sites by the dermatologist using instrument evaluations.
2. Calculation of eczema area by dermatologist using Eczema Area and Severity Index (EASI).
|
1. On Day 01 before application and on Day 14 and Day 28 after product usage
2. On Day 01 before application and Day 14 and Day 28 after product usage
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. cutaneous tolerance/ local irritation i.e. Erythema, Oedema, Dryness, Flaking, Scaling, Itching, Peeling, Pigmentation for body wash and body lotion
2. Global Assessment Scale (IGA) for body wash and body lotion
3. itchiness of skin using Itch NRS scale for body lotion
4. subjective self-assessment i.e. perceived symptoms of irritation such as Burning, Itching, and Stinging for body wash and body lotion
5. subjective perception about product for body wash and body lotion
|
1. On Day 01, Day 14 and Day 28
2. On Day 01, Day 14 and Day 28
3. Day 01 i.e. Baseline, 0 sec before application, to 10 sec, 20 sec, 30 sec, 40 sec, 50 sec, 60 sec, 2 min, 5 min, 10 min and 15 min after application on Day 01.
4. On Day 01, Day 14 and Day 28
5. On Day 14 and Day 28
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2021 |
| Date of Study Completion (India) |
01/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of this study is to evaluate the efficacy of body lotion
on Eczema symptoms improvement in
female subjects with mild to moderate eczema in a 4-week home use test.
For this study, compatibility means that the Test product does not
worsen the skin condition, determined by an assessment of the lesional and
non-lesional skin sites, also cutaneous tolerance of body lotion on Eczema skin
will be assessed. |