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Safety study of cosmetics as per BIS.

Study of safety test of 8 different cosmetic formulations by patch test as per BIS 4011 : 2018 ( Third Revision ).

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/031056
Enrollment
24
Registered
2021-02-05
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: Phototype III to V. Healthy skin on test area. having signed a consent form able to read and write valid id prrof. urine test negative for women.

Exclusion criteria

Exclusion criteria: 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 study treatment or procedures. 7. Chronic illness which may influence the outcome of the study. 8. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 9. Subjects in an exclusion period or participating in another food or cosmetic or therapeutic trial.

Design outcomes

Primary

MeasureTime frame
Evaluation of skin irritation potential ( Occurence of Erythema and Oedema ) w.r.t. Investigational Products at 4th day.Timepoint: at 4th day.

Secondary

MeasureTime frame
To Check Contact Hypersensitivity as per BIS 4011 : 2018 directivesTimepoint: at 4th day.

Countries

India

Contacts

Public ContactSAMEER SHINDE

Sanity Lifesciences Pvt.. Ltd.

sudhir.medhekar@gmail.com9820321430

Outcome results

None listed

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