CTRI/2023/10/058458 [Registered on: 09/10/2023] Trial Registered Prospectively
Last Modified On:
05/10/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Other (Specify) [Cosmeceuitcal ]
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Assessment of Safety & Efficacy of cosmetic products
Scientific Title of Study
To evaluate & compare the in-vivo safety and efficacy of three skin care formulations post routine sun exposure in terms of moisturization, skin radiance, skin brightening, improvement in even skin tone, skin firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/sebum on healthy female subjects.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
XXX-NF02-ZI-MH23; Version:02; Dated: 25/09/2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
dull skin with dark spots (acne PIH), under eye dark circle, oily to mixed oily skin type & dark to wheatish skin
Intervention / Comparator Agent
Type
Name
Details
Intervention
Fairness cream: Product A
Product will be applied on the whole face , twice a day application in morning and evening for the period of 21 days
Intervention
Fairness cream: Product B
Product will be applied on the whole face , twice a day application in morning and evening for the period of 21 days
Intervention
Fairness cream: Product C
Product will be applied on the whole face , twice a day application in morning and evening for the period of 21 days
Comparator Agent
Nil
Not applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
35.00 Year(s)
Gender
Female
Details
1.Indian female subjects
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
4.Having dull skin with dark spots (acne PIH)
5.Having under eye dark circle
6.Having dark to wheatish skin
7.Having oily to mixed oily skin type.
8.Having daily routine involving atleast 2 hours sun exposure
ExclusionCriteria
Details
1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give her assent by not signing the consent form
3 Taking part in another study liable to interfere with this study
4 Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
6 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
7 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
8 Having cutaneous hypersensitivity.
9 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
10 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
11 Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
12 Refusing to follow the restrictions below during the study:Do not take part in any family planning activities leading to pregnancy and breastfeeding. Do not take part in another study liable to interfere with this study. Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). Do not change their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit, During the study: Do not use other cosmetic products than the tested products to the studied areas, The day of the measurements: No test product must be used (only face cleaned with water is accepted)
13 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
14 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
15 Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements.
16 Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months.
17 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
18 Having had beauty treatment (e.g., skin cleansing, exfoliation, scrub, mask …) or having applied self-tanning products in the week preceding the start of the study
19 Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
20 Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
21 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
22 Refusing to follow the restrictions below during the study:Do not start, change or stop a hormonal treatment (hormonal contraception, Hormone Replacement Therapy), Do not start a medicinal treatment which could lead to hyper pigmentation, Do not take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…), Do not consume caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements, Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self-tanning products, Do not use products or techniques or surgery with a depigmenting / whitening action, Do not expose herself to the sun by respecting a strict photo-protection.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Case Record Numbers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
moisturization, skin radiance, skin brightening, improvement in even skin tone
Baseline, 10 minutes, 4 hours post sun exposure, 8 hours, 10 hours, Day 7, 10 minutes after application on day 7, 4 hours after application on day 7, 8 hours after application on day 7, 10 hours after application on day 7, Day 14 , Day 21, 10 hours after application on day 21
Secondary Outcome
Outcome
TimePoints
skin firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/ sebum
Baseline, 10 minutes, 4 hours post sun exposure, 8 hours, 10 hours, Day 7, 10 minutes after application on day 7, 4 hours after application on day 7, 8 hours after application on day 7, 10 hours after application on day 7, Day 14 , Day 21, 10 hours after application on day 21
Target Sample Size
Total Sample Size="108" Sample Size from India="108" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
14/10/2023
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
To evaluate &
compare the in-vivo safety and efficacy of three skin care formulations post
routine sun exposure in terms of moisturization, skin radiance, skin
brightening, improvement in even skin tone, skin firmness, reduction in dark
spots (acne PIH), reduction in under eye dark circles, skin oiliness/sebum on
healthy female subjects.
Primary Objective:
To assess
the efficacy of two skin care formulations, post routine sun exposure in terms
of moisturization, skin radiance, skin brightening, improvement in even skin
tone.
Secondary Objective:
To assess the
efficacy of two skin care formulations, post routine sun exposure in terms of
skin firmness, reduction in dark spots (acne PIH), reduction in under eye dark
circles, skin oiliness/ sebum.
The evaluation is
performed using:Subject Self Evaluation, Dermatological
Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry,
Corneometry, CLBT (Color, Luminosity, Brightness, Transparency), Sebumetery, Mexametry,
Tewametry, Cutometry, Expert Evaluation: Assessment of Transfer-Proof &
Water-Proof Efficacy, Analysis of the skin color through cross polarized light ,
Illustrative Images of whole face & ¾ th face under Diffused Light
The
study lasts 21 days following first application of the test product on the whole
face.