Assessment of Safety & Efficacy of cosmetic products

Not yet recruiting

• Conditions: dull skin with dark spots (acne PIH), under eye dark circle, oily to mixed oily skin type & dark to wheatish skin

• Registration Number: CTRI/2023/10/058458
• Lead Sponsor: EMAMI LTD.

Brief Summary

OBJECTIVETo evaluate &compare the in-vivo safety and efficacy of three skin care formulations postroutine sun exposure in terms of moisturization, skin radiance, skinbrightening, improvement in even skin tone, skin firmness, reduction in darkspots (acne PIH), reduction in under eye dark circles, skin oiliness/sebum onhealthy female subjects.

 Primary Objective:

To assessthe efficacy of two skin care formulations, post routine sun exposure in termsof moisturization, skin radiance, skin brightening, improvement in even skintone.

 Secondary Objective:

To assess theefficacy of two skin care formulations, post routine sun exposure in terms ofskin firmness, reduction in dark spots (acne PIH), reduction in under eye darkcircles, skin oiliness/ sebum.

The evaluation isperformed using:Subject Self Evaluation, DermatologicalEvaluation: 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

Thestudy lasts 21 days following first application of the test product on the wholeface.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-10
• Study Start: 2023-10-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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 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 Measures

Name	Time	Method
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

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