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Safety assessment of products on skin

Evaluation of irritation potential of Skin Care Formulations on healthy human subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016288
Enrollment
24
Registered
2018-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

None listed

Interventions

Intervention1: Deodorant Brand Name: SKORE(SD-002) Deodorant Brand Name: SKORE(SD-006) Deodorant Brand Name: SKORE(SD-007) Deodorant Brand Name: SKORE(SD-008) Deodorant Brand Name: SKORE(SD-009)

Sponsors

TTK Healthcare Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.) Subjects willing to come for regular follow up and ready to follow instructions during the study period

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To evaluate the irritation potential on healthy human subjects of Skin Care Formulations.Timepoint: T0 (Evaluation of test sites by Dermatologist and Subject, Patch application) T1(Patch removal, Evaluation of test sites by Dermatologist, T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal) T8 (Evaluation of test sites by Dermatologist and Subject post 1 week of patch removal and tracking the positive cases). Formulations.

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMr Mohit Lalvani

Mascot Spincontrol India Pvt. Ltd.

raji@mascotspincontrol.in022-43349191

Outcome results

None listed

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