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Safety and efficacy assessment of Product on skin

Primary Objective: To evaluate the in-vivo efficacy and safety of Skin care formulation in terms of tan reduction, reduction in pigmentation and skin smoothness on healthy male and female subjects. Secondary Objective: To evaluate the in-vivo efficacy and safety of Skin care formulation in terms of Skin brightness and Skin even tone on healthy male and female subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045260
Enrollment
36
Registered
2022-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Sunscreen SPF 40 (SP6-003): Product to be applied on whole face and neck, twice in a day for the period of 28 days. In morning (before sun exposure) and noon (around 1 PM)}. Control Int

Sponsors

SkinQ
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indian male & 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. Between 18 and 45 years of age. 4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar�.). 5. Having tanned minimal forehead. 6. Having uneven skin tone with pigmentation (Acne PIH / Melasma)

Exclusion criteria

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, â�¦), 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 (phenyto�¯n, amiodarone, metals, minocyclineâ�¦) in the previous 6 months 20. Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroteneâ�¦) 21. Having 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 22. Having applied products with a depigmenting/ whitening action (hydroquinone or derivatesâ�¦) in the 4 weeks preceding the start of the study. 23. Having undergone physical and/o

Design outcomes

Primary

MeasureTime frame
Tan reduction, reduction in pigmentation and skin smoothnessTimepoint: Baseline, Day14, Day28

Secondary

MeasureTime frame
Skin brightness and Skin even toneTimepoint: Baseline, Day14, Day28

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026