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To assess primary skin irritation as per BIS Directives with new cosmetic samples.

A Study of safety test of 7 different cosmetic formulations by patch test on 24 healthy adult human subjects with 1 % SLS as positive control and Isotonic Saline Solution 0.9% as negative control as per BIS directives

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/09/021117
Enrollment
24
Registered
2019-09-09
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 Care 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 course of 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 irritation.Timepoint: 24 hrs after patch removal.

Secondary

MeasureTime frame
To check contact hypersensitivity.Timepoint: 24 hrs after patch removal.

Countries

India

Contacts

Public ContactDr Sudhir Medekar

Sanity Lifesciences

sudhir.medhekar@gmail.com-

Outcome results

None listed

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