Evaluation of safety and efficacy of skin care formulation

Not yet recruiting

• Conditions: Having wheatish to dark complexion, having dry skin 10 Females with sensitive skin

• Registration Number: CTRI/2022/08/044838
• Lead Sponsor: DPKA Universal Consumer Ventures Private Limited

Brief Summary

PRIMARY OBJECTIVE To evaluate the in-vivo efficacy andsafety of a skin care formulation in terms of in terms of skin brightening onhealthy female subjects.

SECONDARY OBJECTIVE To evaluate the in-vivo efficacyof a skin care formulation in terms of improvement in skin hydration and improvementin skin smoothness on healthy female subjects.

Test Product: SUNSCREEN LOTION: Product A

The evaluation isperformed using: Subject’s Self Evaluation, DermatologicalEvaluation: Safety, Dermatological Evaluation: Efficacy, Chromametry,Corneometry.

Total durationof the study: 28 days following the first application of product.

Kinetics: T0, T+30 minutes afterproduct application, T+7 days, T+14 days and T+28 days

Number of volunteers: 56(43 normal skin volunteers +13 sensitive skin)

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-23
• Study Start: 2022-08-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 56

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) 3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar, acne….) Specific criteria 4Having wheatish to dark complexion.
• 5Having dry skin.
• 6Subjects who are passing in skin sensitivity test (only for 13 females).

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 a progressive asthma (either under treatment or last fit in the last 2 years) 6Being epileptic. 7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8Having cutaneous hypersensitivity 9Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10Following 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) 11Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 12Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 13Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted) 14Refusing 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 or skin care products other than the tested products to the studied areas. (only standard facewash is accepted). The day of the measurements: No test product must be used (only face cleaned with water is accepted) Specific criteria 15Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months. 16Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 17Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months 18Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…) 19Having 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 20Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study 21Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 22Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months 23Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 24Refusing 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 use products or techniques or surgery with a depigmenting.
• Do not take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…).
• Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self tanning products action.
• Do not swim in artificial water bodies (pools, hot tubs etc.…).
• 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
skin brightening, skin safety	Baseline, 30 min after product application, 7 days, 14 days and 28 days

Secondary Outcome Measures

Name	Time	Method
improvement in skin hydration	and improvement in skin smoothness

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