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A Study of safety test of 2 different cosmetic formulations.

Study of irritancy of 2 cosmetic products in terms of irritant potential as per BIS directives.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/10/021744
Enrollment
24
Registered
2019-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

None listed

Sponsors

Godrej Consumer Products Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Volunteer (Male / Female) between 18 to 65 years old 2 Phototype III to V 3 Having apparently healthy skin on test area 4 For whom the investigator considers that the compliance will be correct. 5 Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures. 6 Having signed a Consent Form. 7 Willingness to avoid excessive water contact (for example: swimming) or activity which causes excessive sweating (i.e., exercise, sauna), during the study. 8 Should be able to read and write (i.e., in English, Hindi and Local Language). 9 Having valid proof of identity and age.

Exclusion criteria

Exclusion criteria: 1 Pregnant/nursing mothers. 2 Scars, excessive terminal hair or tattoo on the studied area. 3 Henna tattoo anywhere on the body (in case of studies involving hair dyes). 4 Dermatological infection/pathology on the level of studied area. 5 Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye). 6 Any clinically significant systemic or cutaneous disease, which may interfere with the study treatment or procedures. 7 Chronic illness which may influence the outcome of the study

Design outcomes

Primary

MeasureTime frame
To assess skin irritationTimepoint: 24 hrs after patch removal as per BIS Directives.

Secondary

MeasureTime frame
To check contact hypersensitivity.Timepoint: 24 hrs after patch removal as per BIS directives.

Countries

India

Contacts

Public ContactDr Sudhir V Medhekar

Sanity Lifesciences Pvt Ltd

sudhir.medhekar@gmail.com9820321430

Outcome results

None listed

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