| CTRI Number |
CTRI/2021/02/031493 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
29/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [in-use skin compatibility and cosmetic acceptability study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety study of face soap |
|
Scientific Title of Study
|
A single centre, prospective, multiple arms, randomised, open label, 7-day study to assess under dermatological control, the in-use skin compatibility and cosmetic acceptability of a range of four Dettol bar soaps for use on the face |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00646 (5044801) Version: 01, Dated 08 Jan 21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| 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 |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| 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
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Maheshvari Patel |
| Designation |
Associate 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 |
9909013236 |
| Fax |
07966219549 |
| Email |
mnpatel@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Reckitt Benckiser Health Limited |
| Address |
Reckitt Benckiser Health Limited
Dansom Lane South, Hull, HU8 7DS
|
| Type of Sponsor |
Other [Health and Hygiene Industries] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
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 |
9909013286
07966219549
nkpatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS - IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18 to 55 years healthy adult male & female |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Santino Cool 2x
2. Basil Earth
3. Original (High Total Fatty Matter (TMF))
4. Amaze Original LUP
|
Soap to be used on face twice daily for seven days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Subject able to give written informed consent and from whom written informed consent has been obtained.
2) Healthy male and female subjects between the ages of 18 and 55 years inclusive at the time of informal consent.
3) Subject with Fitzpatrick Scale Phototype III to V skin
4) Subjects who are able to understand the study, co-operate with the study procedures and prohibitions, and are able to attend all study assessments.
|
|
| ExclusionCriteria |
| Details |
1) Female subject who is pregnant (self-report), lactating, have given birth within the previous 3 months or are planning to become pregnant in the duration of the study.
2) Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
3) Subject with known skin disorders (acne, psoriasis, eczema, rosacea, or other).
4) Subjects with dry or sensitive skin on the face (interrogation of skin type by questionnaire and dermatologist assessment).
5) Subject with dryness or irritation on the face or hands at the screening.
6) Subject with known allergies to any of the test product ingredients.
7) Subject with excessive hair growth on the face that in opinion if the Investigator will hinder visual assessment of the test site. Subjects with freckles, beauty spots, birthmarks, or a tattoo at the test site.
8) Subject with a history of type 1 or type 2 diabetes.
9) Subject with peripheral vascular disease or poor blood circulation (self-reported).
10) Subject with a significant past medical history of the hepatic, renal, cardiac, pulmonary, digestive, haematological, endocrinological, neurological, locomotor, or psychiatric disease which, in the opinion of the investigator, would compromise the safety of the subject.
11) Subject with a history of skin tumours or malignant disease.
12) Subject whose skin has been excessively exposed to the sun or to UV rays during the previous month in the opinion of the Investigator.
13) Subject who is suffering from chronic asthma, a malfunction of the lymphatic system, or an autoimmune deficiency disease (e.g. lupus, thyroiditis).
14) Subject taking antihistamine or steroid preparations, any medication for the treatment of diabetes mellitus, immunosuppressive drugs, or any other medication which, in the opinion of the investigator, may affect the test results.
15) Subject who has a history of excessive drug or alcohol use (in line with national guidance) which will affect the test results in the opinion of the Investigator.
16) Subject with any conditions, which in the opinion of the investigator, may affect the results of the study.
17) Subject who has participated in any clinical study during the previous month or are currently participating in a separate clinical study.
18) Employee at the study site.
19) Any partner or first-degree relative of the subject who has a role in the study at the vendor site.
20) Subject unable in the opinion of the Investigator to comply fully with the study requirements.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the in use cutaneous compatibility of each of the four test formulations when used on the face for 7 days |
An assessment of the Mean Irritation Index (M.I.I.) at 30 mins post initial use and after 7 days in-use. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Subject self-assessment of tolerance on Days 1-7 with use of SPQs.
2. Dermatologist Global assessment of tolerance at Day 7 for each Subject.
3. An overall assessment of the in-use tolerance for all subjects by the Dermatologist at the end of the study.
4. Prevalence of any adverse events.
|
1. Day 1 and Day 7
2. Day 7
3. Day 7
4. Day 1 and Day 7
|
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2021 |
| Date of Study Completion (India) |
24/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
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
|
A single
center, prospective, multiple arms, randomised, open-label, 7-day study to
assess under dermatological control, the in-use skin compatibility and cosmetic
acceptability of a range of four Dettol bar soaps for use on the face. The
study will be performed on behalf of RB by Cliantha. The dermatologist
appointed by Cliantha will assess skin type and other subject selection
criteria for each subject recruited to the study.
The test
site for this study will be the full face. Dermatologist cutaneous assessment
of the test site test will be visually assessed for irritation at 30 minutes
post initial use and following 7 days in use as per the irritancy grading scale.
The study is
designed to evaluate if the test products will cause a drying effect with
repeated use and if this effect will cause irritation on facial skin.
SPQs have
been included to provide a subjective assessment of the test product tolerance
(i.e. feeling of dryness / tightness / smoothness).
Subjects
will use the product to cleanse their face at least once daily. The test
products should not be used more than twice daily. |