| CTRI Number |
CTRI/2021/05/033909 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
29/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [consumer cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
A Consumer Research Study to Evaluate the moisturization properties of Test Products in Healthy Adult & Adolescent Human Subjects |
|
Scientific Title of Study
|
A Single Center, Application Site Randomized, Evaluator-Blinded, Moisturization Study to Evaluate the moisturization properties of Test Products in Healthy Adult & Adolescent Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00990 Version: 01, Dated 11 May 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 Ahmadabad GUJARAT 380054 India |
| Phone |
9909013286 |
| Fax |
917966219549 |
| 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 Ahmadabad GUJARAT 380054 India |
| Phone |
9909013286 |
| Fax |
917966219549 |
| 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 Ahmadabad GUJARAT 380054 India |
| Phone |
9909013236 |
| Fax |
917966219549 |
| Email |
mnpatel@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Limited |
| Address |
Zydus Wellness Limited
House No 2 3 4 5
Sigma Commerce Zone
Near Iskcon Temple S G Highway
Ambli Bopal Road
Ahmedabad 380015 |
| Type of Sponsor |
Other [Health and Hygiene Industries] |
|
|
Details of Secondary Sponsor
|
|
|
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 Ahmadabad GUJARAT |
9909013286 917966219549 nkpatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults subjects between ages of 18 to 30 (both inclusive) years old and in the age range from 13 to 17 Years (inclusive of both genders) at the time of consent |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moisturizer A |
White Color Lotion with characteristic odour; 50 mg ; single dose ; topical
|
| Intervention |
Moisturizer B |
White Color Lotion with characteristic odour; 50 mg ; single dose ; topical |
| Intervention |
Moisturizer C |
White Color Lotion with characteristic odour; 50 mg ; single dose ; topical |
| Intervention |
Moisturizer D |
White Color Lotion with characteristic odour; 50 mg ; single dose ; topical |
| Intervention |
Moisturizer E |
Off White to White Color beads suspended into opaque gel; 50 mg ; single dose ; topical |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults subjects between ages of 18 to 30 (both inclusive) years old and in the age range from 13 to 17 Years (inclusive of both genders) at the time of consent.
2) Subject general in good health as determined from a recent medical history.
3) Subject is willing to participate in the study, give a voluntary written informed consent OR an assent and consent of the respective Legal guardian in case of adolescent subjects.
4) Subjects willing to abide by and comply with the study protocol.
5) Subjects should not participate in any other clinical study during participation in the current study
|
|
| ExclusionCriteria |
| Details |
1) Use of Body milk /lotion / cream, cosmetics or any other body moisturizing product before 3-5 days prior to study and during the study period.
2) Chronic illness which may influence the cutaneous state.
3) Subjects on any systemic medication.
4) Subject with history of diabetes
5) Subjects participating in a similar clinical study, currently or during the previous 30 days.
6) Any Subjects, in the Investigator opinion not considered suitable for enrollment.
7) A known history or present condition of allergic response to any other concern that may require medical attention.
8) Adults with medical history (past/present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of test product(s) on skin moisture i.e. hydration state of the skin change from baseline
2. To assess the effect of test product(s) on skin barrier function
3. To assess the effect of test product(s) on skin physical parameter using 5-point scoring scale for skin dryness, skin roughness, skin suppleness and softness, skin redness/erythema, burning, itching and stinging from baseline
|
1. Day 1 before application to T4 hours T8 hours T24 hours and T48 hours
2. Day 1 before application to T4 hours T8 hours T24 hours and T48 hours
3. Day 1 before application to T4 hours T8 hours T24 hours and T48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 To assess Product response index (perception about product) after application |
1 On Day 3 |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2021 |
| Date of Study Completion (India) |
16/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="3" |
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 physiological mechanism of
skin moisturization consists of a stratum corneum (SC) containing 10–15% water
in order to remain flexible and elastic. The SC comprises predominantly
hydrophobic substances and is an essential factor that slows down corneocyte
dehydration and ensures enzymatic activity. Dry skin is characterized by a
moisture content of less than 10%, which is coherent with a loss of continuity
of the SC. Transepidermal water loss (TEWL) is the most widely used surrogate
marker for skin barrier function
Moisturizers
enhance the water-holding capacity of the skin. They are commonly used by all
age groups and in both genders regardless of the presence of a skin disease.
Functional skin benefits are sought with application of these products on
facial skin by making the skin soft and smoother, increasing skin hydration and
skin rejuvenation. Indeed, the application of moisturizers achieves an
appearance benefit. However, recent studies suggest that long-term therapy with
moisturizers not only strengthens but also weakens the skin barrier function
and may influence its recovery subsequent to damage . Adequate skin hydration is
critical for maintaining healthy skin, and moisturizers are an important
component of basic skin care. The ability of the skin to hold water is
primarily related to the stratum corneum (SC), which plays the role of barrier
to water loss. The importance of SC water content to “normal†nonflaky skin
appearance has long been known, with healthy tissue containing >10% water SC intercellular lipids
orderly arranged to form a barrier to transepidermal water loss (TEWL). The
intercellular lipid organization and consequently the SC barrier properties are
also linked to the existence of a lipid gradient as demonstrated in the dermis,
hyaluronic acid (HA), a high molecular weight glycosaminoglycan with markedly
hydrophilic properties, contributes to the hydration and plastic properties of
the skin The skin’s primary function is
to provide a protective barrier that maintains internal nourishing hydration
and electrolytes while preventing entry of exogenous substances such as
bacteria, allergens, particulates, pollution, etc. The outermost layers of the
skin, the stratum corneum (SC), are often described as a bricks
(cells)-and-mortar (lipid) structure. Scientist and clinicians believe that
this structure creates a tortuous path through the “mortar†that inhibits the
flow of water from the skin and contaminants into the skin The children’s skin
is sensitive and prone to irritation and eczema. Skin care is important
especially in infancy as the skin barrier matures during the first year of
life. Many children’s have some areas of dry skin. During the children usually
need extra care and moisturization for their skin. Some children’s have skin
that is very dry and splits, especially around the ankles and hands. Hence, you
may need to
use cream to moisturize. The adult’s skin
is sensitive and prone to irritation and eczema. Skin care is important. Some
adults have skin that is very dry and splits, especially around the ankles and
hands. Hence, you may need to
use cream to moisturize or soothe skin irritation. Adult’s moisturizers
that is mild and fragrance-free keeps newborn’s skin from becoming too dry. If
you want to use cream, choose one that does not have perfume or dyes, such as
Aquaporin or Eucerin The
aim of this observational study is determined the effect
of moisturizers properties of various moisturizers on all skin types in healthy
adults and adolescent subjects. The proposed benefits are evaluated by the
dermatologist/dermatologist trained evaluator and assessment questionnaire at
24 hours, 48 hours after test product application. The instrumental evaluation
of skin hydration will be done at before application to 4
hours, 8 hours, and 24 hours and 48 hours after test product application |