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Safety & efficacy assessment of products on skin

To evaluate the in-vivo safety and efficacy of leave on and rinse off Skin Care formulations and comparison (of Treated versus Untreated Area) in terms of skin moisturization on healthy human subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/050055
Enrollment
33
Registered
2023-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

None listed

Interventions

Intervention1: 2% AQUA GF (Cream): 6 sites of3 x 3 cm2 are marked on forearms. Application of 20 µl of test products is carried out once at randomized area of 3 x 3 cm2 on inner forearms for the perio

Sponsors

GREEN FARM CARE PRODUCTS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indian male and 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 35 years of age. 4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….). 5. Having dry skin on inner forearms.

Exclusion criteria

Exclusion criteria: 1. For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2. Having refused to give his/her assent by not signing the consent form and Informed consent form 3. Taking part in another study liable to interfere with this study 4. Being known diabetic case 5. Known asthma case 6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7. Being known thyroid case 8. Being epileptic. 9. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol) 10. Known case of hypersensitivity. 11. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 12. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13. Having changed their cosmetic habits except those required by the protocol 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 48 hours prior study. 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, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol). - Do not change 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 product to the studied areas. 16. Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid…) in the past 3 months. 17. Having taken an oral retinoid-based treatment in the past 6 months 18. Having taken a local retinoid-based treatment on the studied areas in the previous month 19. Having had beauty treatment (e.g. scrub, manicure, self-tanning product …) in the previous week 20. Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week. 21. Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 22. Having practiced intensive sports during the day prior to the T0 measurements 23. Having wounds, scars, sunburns, tattoos and piercing on test site. 24. Having hair on test site. 25. Having applied another product than water on the studied areas in the morning of the T0 measurements 26. Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements. 27. Having used moisturizing products on the arms during 24 hours prior to T0 measurements. 28. Refusing to follow the restrictions below during the study: - Do not have

Design outcomes

Primary

MeasureTime frame
skin moisturizationTimepoint: Baseline, 10 minutes after product application, 4 hours after product application, 8 hours after product application, 12 hours after product application, 24 hours after product application, 48 hours after product application & 72 hours after product application

Secondary

MeasureTime frame
NilTimepoint: Not applicable

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