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Safety assessment of cosmetic Product

To evaluate the irritation potential on healthy human subjects having Varied skin types of Skin Care Formulations - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073230
Enrollment
26
Registered
2024-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

None listed

Interventions

Intervention1: KA RUPA OIL: 40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded pat

Sponsors

Kama Ayurveda Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….). 3) Subjects willing to come for regular follow up and ready to follow instructions during the study period. 4) Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination)

Exclusion criteria

Exclusion criteria: 1 For female: 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 3 Taking part in another study liable to interfere with this study 4 Being diabetic. 5 Being asthmatic. 6 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). 7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months. 10 Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.

Design outcomes

Primary

MeasureTime frame
Dermatological safety / Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs and 7 days

Secondary

MeasureTime frame
NilTimepoint: NA

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