Safety and efficacy assessment of Product on skin

Not yet recruiting

• Conditions: having wheatish to dark complexion

• Registration Number: CTRI/2022/11/047232
• Lead Sponsor: VEDISTRY PVT LTD.

Brief Summary

**Secondary Objective:** To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of improvement in skin radiance, skin brightness, skin smoothness, Skin firmness and reduction in intensity of dark spoton healthy female subjects.

Duration of study: 28 days study

Kinetics: T0, T+15 Minutes after product application, T+14 days and T+28 days

Population: 36 Female volunteers

The evaluation is performed using:

1       1. Subject’s Self Evaluation, 2       Dermatological Evaluation: Cosmetic Acceptability,  3       Dermatological Evaluation: Efficacy,  4       Chromametry , 5       Mexametry , 6       CLBT , 7   Cutometry

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 36

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 45 years of age.
• 4Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
• 5Having wheatish to dark complexion.
• 6Having dark spot (acne PIH) on face and at least one spot of 3.5 mm diameter.

Exclusion Criteria

• 1. For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2. For Male: Shave beard 1day prior before visit 3. Having refused to give his/her assent by not signing the consent form 4. Taking part in another study liable to interfere with this study 5. Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6. Having acne prone skin. 7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products. 9. 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). 10. Having cutaneous hypersensitivity. 11. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 12. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 14. 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) 15. Refusing to follow the restrictions below during the study: For Females: 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) 16. Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months. 17. Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months. 18. Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 19. Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months 20. Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…) 21. 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 22. Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 23. Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months 24. Having a suntanned skin on the studied areas which could interfere with the evaluations of the study. 25. 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
Improvement in	Baseline, 15 minutes | after product | application, Day14, Day28
skin radiance, skin brightness, skin smoothness, Skin firmness and reduction in intensity of dark spot	Baseline, 15 minutes | after product | application, Day14, Day28

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