Safety & Efficacy check of cosmetic product

Not yet recruiting

Conditions: having dull skin with dark spots of acne PIH, under eye dark circle, oily to mixed oily skin type & dark to wheatish skin

Registration Number: CTRI/2023/04/051906

Lead Sponsor: EMAMI LTD.

Brief Summary: OBJECTIVETo evaluate & comparethe in-vivo safety and efficacy of two skin care formulations post routine sunexposure in terms of moisturization, skin radiance, skin brightening,improvement in even skin tone, skin firmness, reduction in dark spots (acnePIH), reduction in under eye dark circles, skin oiliness/sebum on healthyfemale subjects

Primary Objective: To assess the efficacy oftwo skin care formulations, post routine sun exposure in terms ofmoisturization, skin radiance, skin brightening, improvement in even skin tone.

SecondaryObjective: Toassess the efficacy of two skin care formulations, post routine sun exposure interms of skin firmness, reduction in dark spots (acne PIH), reduction inunder eye dark circles, skin oiliness/ sebum.

Product :Fairness Cream1, Fairness Cream 2

The evaluation is performed using:Subject SelfEvaluation, Dermatological Evaluation: Cosmetic Acceptability, DermatologicalEvaluation: Efficacy, Chromametry, Corneometry, CLBT (Color, Luminosity,Brightness, Transparency), Sebumetery, Mexametry, Tewametry, Cutometry, ExpertEvaluation: Assessment of Transfer-Proof & Water-ProofEfficacy, Analysis of the skin color through cross polarized light ,Illustrative Images of whole face & Â¾ th face under Diffused Light

Totalduration of the study: 21 days

Kinetics:Day 1 (T1)- T0, T+10 minutes(T2), T+4 hours (post sun exposure) (T3), T+8 hours (T4), T+10 hours (T5), Day7 (T6)-T+7 days, T+10 minutes (T7), T+4 hours (post sun exposure) (T8), T+8hours (T9), T+10 hours (T10), Day 14 (T11)- T+14 Days, Day 21 (T12)- T+21 Days,T+10 minutes (T13), T+4 hours (post sun exposure) (T14), T+8 hours (T15), T+10hours (T16)

Productapplication: Twice a day, morning and evening

Numberof volunteers: 72 (36 perproduct) female subjects.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 72

Inclusion Criteria

1Indian female subjects 2Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3Between 18 and 35 years of age.
4Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 5Having dull skin with dark spots (acne PIH) 6Having under eye dark circle 7Having dark to wheatish skin (L between 45 to 55) 8Having oily to mixed oily skin type 9Having daily routine involving atleast 2 hours sun exposure.

Exclusion Criteria

1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2Having refused to give her assent by not signing the consent form 3Taking part in another study liable to interfere with this study 4Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 6Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
7Following 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).
8Having cutaneous hypersensitivity.
9Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
10Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
11Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted) 12Refusing 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) 13Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 14Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 15Having consumed caffeine-based products (coffee, cola, tea, â€¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements.
16Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoÃ¯n, amiodarone, metals, minocyclineâ€¦) in the previous 6 months.
17Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-caroteneâ€¦) 18Having had beauty treatment (e.g., skin cleansing, exfoliation, scrub, mask â€¦) or having applied self-tanning products in the week preceding the start of the study 19Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study 20Having applied products with a depigmenting/ whitening action (hydroquinone or derivatesâ€¦) in the 4 weeks preceding the start of the study.
21Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 22Refusing 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-caroteneâ€¦), Do not consume caffeine-based products (coffee, cola, tea, â€¦), 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 â€¦) 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
moisturization, skin radiance, skin brightening, improvement in even skin tone	Baseline, 10 minutes, 4 hours, 8 hours, 10 hours, 7 days (10 minutes, 4 hours, 8 hours, 10 hours), Day 14(10 minutes, 4 hours, 8 hours, 10 hours), Day 21(10 minutes, 4 hours, 8 hours, 10 hours)

Secondary Outcome Measures

Name	Time	Method
firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/ sebum	Baseline, 10 minutes, 4 hours, 8 hours, 10 hours, 7 days (10 minutes, 4 hours, 8 hours, 10 hours), Day 14(10 minutes, 4 hours, 8 hours, 10 hours), Day 21(10 minutes, 4 hours, 8 hours, 10 hours)

Trial Locations

Locations (1): Mascot Spincontrol India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Raji Patil
Principal investigator
02243349191
raji@mascotspincontrol.in