Skip to content

Safety Patch test on healthy human subjects

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types - not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/01/007643
Enrollment
24
Registered
2017-01-06
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. Deodorant (4131A) 2. Deodorant (4131C) 3. Deodorant (4131E) 4. Deodorant (6091D) 5. Rinse Off (56-37) 6. Rinse Off (56-38) 7. Rinse Off (R 473) 8. Rinse Off (21803A) 9. Rinse Off (TS
the product is leave on product, so are placed directly in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit Control Intervention1: Sodium Lauryl Sulphate (SLS

Sponsors

ITC LIMITED ITC Life Sciences and Technology Centre
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 Timepoint: t0 t1 t2 t8

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL

mohit@mascotspincontrol.in

Outcome results

None listed

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