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Study to check the safety and effectiveness of products on human volunteers

To evaluate and compare the in-vivo safety and efficacy of Skin Care Formulation verses Untreated Control in terms of skin moisturization and skin barrier function on healthy female subjects - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079167
Enrollment
33
Registered
2025-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

None listed

Interventions

Intervention1: Oryza Acne Cream: The Product is applied on marked site of 3 x 3 cm2 on inner forearm once at site and left at is for 72 hours. Application is done only one time and site will be kept a

Sponsors

Alembic Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Indian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Subject having dry skin on forearms.

Exclusion criteria

Exclusion criteria: 1. 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, corticotherapy, 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. Refusing to follow the restrictions below during the study: 1. Do not take part in any family planning activities leading to pregnancy and breastfeeding. 2. Do not take part in another study liable to interfere with this study. 3. 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) 4. Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit 5. During the study: Do not use other cosmetic products than the tested products to the studied areas. Specific criteria 1. Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid ) in the past 3 months. 2. Having taken an oral retinoid-based treatment in the past 6 months 3. Having taken a local retinoid-based treatment on the studied areas in the previous month 4. Having had beauty treatment (e.g. scrub, manicure, self-tanning product ) in the previous week 5. Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week. 6. Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week 7. Having consumed caffeine-based products (coffee, cola, tea, ), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 8. Having practiced intensive sports during the day prior to the T0 measurements 9. Having wounds, Scars, sunburns, tattoos and piercing on test site. 10. Having hair on test site. 11. Having applied another product than water on the studied areas in the morning of the T0 measurements 12. Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements. 13. Having used moisturizing products on the arms during 24 hour

Design outcomes

Secondary

MeasureTime frame
NilTimepoint: NA

Primary

MeasureTime frame
skin moisturization and skin barrier functionTimepoint: T0, 30 Minutes, 24 hours, 48 hours & 72 Hours after product application

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

poojayadav@mascotspincontrol.in02243349191

Outcome results

None listed

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