| CTRI Number |
CTRI/2020/02/023247 [Registered on: 11/02/2020] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Care] |
| Study Design |
Other |
|
Public Title of Study
|
Impact of topical application of Test Product on skin hydration, moisturisation and microorganisms regulation. |
|
Scientific Title of Study
|
A single centre, site randomized, double-blind, comparative study to evaluate the impact of topical application of FOS and GOS on skin hydration, barrier function, and microbiome regulation in human adult subjects with dry, flaky skin, otherwise healthy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KLS19-TCL-276 Version 00 dated 13 Jan 20 |
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 |
Tata Chemicals Ltd |
| Address |
Survey No 315 Hissa No 1 14
Paud Road Ambedveth Mulshi
Pune Maharashtra 412111
Phone 020 6654 9700
Fax 020 66549735
|
| Type of Sponsor |
Other [FMCG] |
|
|
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 917968221100
Fax 917966219549
Ahmadabad
GUJARAT |
9909013286
07966219549
nkpatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With dry, flaky skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product 1: Control (Base cream without any moisturizing ingredients)
Test Product 2: 5% Fructo-Oligosaccharide (5% FOS)
Test Product 3: 5% Galacto-Oligosaccharide (5% GOS)
Test Product 4: 2.5% Fructo-Oligosaccharide and 2.5% Galacto-Oligosaccharide (2.5% FOS and 2.5% GOS) |
Test products Approx 2g to be applied on subjects volar forearms i.e. 2 into 2 cm2 test site as per randomization schedule for 14 days daily application |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 30 to 55 years (both inclusive) at the time of consent.
2. Sex: Male or non-pregnant/non-lactating females.
3. Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit.
4. Subject who is having good general health as per medical history.
5. Subject with dry skin evaluated by Corneometer reading in between 30 to 40 a.u. unit on each forearm.
6. Subject with mild to moderate dry skin will be included as determined by dermatologist/dermatologist validated scorer using 4 point scale1.
7. Subject with willingness to avoid usage of soaps, cleansers or any other moisturizers/lotions/creams/oils other than the test product on the test site 7 days prior and throughout the entire study duration.
8. Subject must be able to understand and provide written informed consent to participate in the study.
9. Subject should be willing and able to follow the study directions to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Subject with current use or use in the past 3 months of antimicrobial or steroidal drugs or any prescription medication or supplement’s.
2. Subject with medical history (past and present) of significant dermatologic diseases or conditions, such as atopy, psoriasis, eczema, atopic dermatitis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.
3. Subject with history of medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV).
4. Subject with application of any topical products (cream /lotion/soap/Cleanser/coconut oil/mustard oils/ dairy products or any other cosmetic applications, mehndi, tattoo, scar and excessive terminal hair) for 7 days before the study and during the study.
5. Female volunteers who identified Pregnant during the study period or are lactating.
6. Subject with history of drug and alcohol abuse.
7. Subject participating in a similar clinical study, currently or during the previous 90 days.
8. Subject with any relevant surgical treatment during the previous two months or planned during the study.
9. Any subject, in the investigators opinion not considered suitable for enrollment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Effect on skin hydration using Corneometer 2. Effect on skin barrier function using TEWAmeter 3. effect on skin elasticity using Cutometer 4. effect on skin surface using pH meter 5. effect on skin physical parameter by Dermatologist/dermatologist validated scorer scale for dryness, roughness, redness/erythema, burning, itching and stinging 6. effect of products for change in skin microbial flora by swab collection 7. subject response index after application |
1 to 4. Baseline i.e. Day 1 before application to T0.5 hour, T2 hours, T4 hours, T8 hours, T12 hours on Day 1, T24 hours on Day 2, Day 8, Day 14 post application. 5. From baseline i.e. Day 1 (before application) to Day 14 (end of study). 6.From baseline i.e. Day 1 (before application) to Day 14 (end of study). 7. On Day 1, Day 8 and Day 14 (end of study). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2020 |
| Date of Study Completion (India) |
18/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
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)?
|
|
Brief Summary
|
A single centre, site randomized, double-blind, comparative study to
evaluate the impact of topical application of FOS and GOS on skin hydration,
barrier function, and microbiome regulation in human adult subjects with dry,
flaky skin, otherwise healthy.
Test
products will be tested against controls involving 30 subjects. Total study
duration is 14 days. |