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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  
Not Applicable 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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