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Safety assessment of cosmetic Product

The objective of this study will be to evaluate the irritation potential on healthy human subjects of Skin and Hair Care Formulations. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073167
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: Roghan Surkh: 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 pa

Sponsors

Hamdard Laboratories
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Asian Indian male and female subjects 2) Healthy human 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 check-up) 3) Between 18 and 65 years of age 4) Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….)

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 of test products, Irritation potential of test productsTimepoint: Baseline,0 hrs,24 hrs & 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