Assessment ofsafety & Efficacy of cosmetic product

Completed

• Conditions: Healthy females, aged between 35 and 55 years old,having crow’s feet wrinkles & fine lines on the face, having uneven skin tone, having dark spot (age spot) and at least one spot of 3.5 mm diameter

• Registration Number: CTRI/2022/12/048214
• Lead Sponsor: Transformative Learning Solution Pvt Ltd

Brief Summary

PRIMARYOBJECTIVE To evaluate the efficacy and safety of a skin care formulation interms of improvement in skin brightness and skin even tone on healthy femalesubjects.

SECONDARYOBJECTIVE To evaluate the efficacy and safety of a skin care formulation interms of reduction in appearance of wrinkles & fine lines, improvement inskin moisturization and skin firmness, reduction in the density of dark spots(age spots) on healthy female subjects.

Product : Manjish Glow Night - Time Elixir (Sample-D)  : Product A

The evaluation is performed using: Subject’s SelfEvaluation, Dermatological Evaluation: Safety, Dermatological Evaluation:Efficacy, Chromametry (L\* and ITA° parameter for skin brightness& Delta E parameter for skin even tone), Corneometry (Capacitanceparameter Skin Moisturization), Cutometry (R0 parameter for skin firmness), IllustrativeImages of the whole face and 3/4th face under diffuse light

Total duration of the study: 60 days following the firstapplication of product.

Kinetics: T0, T+8 hours after product application, T+7days, T+21 days, T+45 days and T+60 days

Product application : Once in a day at night  application on whole face for the period of 28days

Number of volunteers: 36 female subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Study Completion: 2023-03-13
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

1)Indian or Asian female subjects 2)Healthy 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) 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 4) Having uneven skin tone 5) Having wrinkles on Crows feet area with a grade of 2 (mild) to 4 (moderate) according to the Bazin Atlas 6) Having dark spot (age spot) and at least one spot of 3.5mm diameter.

Exclusion Criteria

• 1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2Having refused to give her assent by signing the consent form 3Taking part in another study liable to interfere with this study 4Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 6Having a progressive asthma (either under treatment or last fit in the last 2 years) 7Being epileptic 8Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9Having cutaneous hypersensitivity 10Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 11Having known allergy to any of the Ingredient of the Test Product. 12Following 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) 13Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 14Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 15Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted) 16Refusing 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 her 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 (only usual cleanser/soap is accepted) ; The day of the measurements: No test product must be used (only face cleaned with water is accepted) 17Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 18Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 19Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 20Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months 21Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…) 22Having 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 23Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid) in the 2 weeks preceding the start of the study. 24Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 25Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months 26Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 27Refusing 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 start an oral or local retinoid-based treatment.
• 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 action.
• Do not practice sport the days of study.
• Do not expose yourself to the sun by respecting a strict photo-protection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in skin	baseline, 8 hours after product application, 7 days, 21 days,45 days, 60 days
brightness and skin even tone	baseline, 8 hours after product application, 7 days, 21 days,45 days, 60 days

Secondary Outcome Measures

Name	Time	Method
reduction in appearance of	wrinkles & fine lines, improvement in skin moisturization and skin firmness, reduction in the density

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