Skip to content

Safety testing by Patch test

To know the safety of Investigational products by assessing the irritation after patch application on healthy human volunteers - not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007673
Enrollment
24
Registered
2017-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: 1. Skin Leave ââ?¬â??On(4822) 2. Skin Leave ââ?¬â??On(4803) 3. Skin Leave ââ?¬â??On(6075) 4. Skin Leave ââ?¬â??On(6082) 5. Deodorant (6091A) 6. Deodorant (6091B) 7. Deodorant (6091C
the products are leave on products so are placed directly in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit 4. For products 13 & 20, The products are diluted

Sponsors

ITC LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scarââ?¬Â¦.) Subjects representing varied skin types (ideally equal representation of all 4 skin types ââ?¬â?? Oily, Normal, Dry and combination) 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 dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types screening, T0, T1, T2, T8 Timepoint: screening, T0, T1, T2, T8

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMr Mohit Lalvani
mohit@mascotspincontrol.in022-43349191

Outcome results

None listed

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