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Safety evaluation of cosmetic products on human volunteers

Evaluation of the dermatological safety of investigational products on healthy human volunteers with sensitive skin - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089252
Enrollment
40
Registered
2025-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None listed

Interventions

Intervention1: Perfume (13-175B): Product application as per BIS standard Intervention2: 13-175A: Product application as per BIS standard Intervention3: 13-175B: Product application as per BIS standar

Sponsors

ITC LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Female and male Asian Indian subjects. 2)Skin is healthy on the studied anatomic unit 3)Subjects who have not participated in a similar investigation in the past eight weeks. 4)Subjects representing sensitive skin type and varied skin type (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, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis. 2) Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area. 3)Having healing disorder in the concerned area. 4)Having rhinitis, allergic conjunctivitis, or rhino sinusitis. 5) Having an allergy to perfumes and/or preservatives in cosmetic products. 6)Having an allergy to plaster / adhesives used in plaster. 7) Having a food allergy. 8)Having a cardiovascular pathology that requires beta blocking treatments. 9)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. 10)Taking a retinoid-based treatment by general or oral route. 11)Taking specific treatment on the back. 12) Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study. 13)Having miliaria (prickly heat) on the back. 14) Presenting too many neavi on the back. 15) Having high pilosity on the back.

Design outcomes

Primary

MeasureTime frame
Dermatological safety / Irritation potential on skinTimepoint: Baseline, 0 Hours, 24 Hours 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