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Safety study for irritant potential of cosmetic formulations viz. deodorants and soaps as Bureau of Indian Standards directives

Study of irritancy of 6 deodorants and 3 soaps as per BIS 4011 : 2018 (Third Revision )

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/01/023043
Enrollment
24
Registered
2020-01-30
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: 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 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: 4th day of study

Secondary

MeasureTime frame
to check contact hypersensitivity as per BIS 4011 : 2018 directivesTimepoint: Evaluation on 4th day ( last day ) of study

Countries

India

Contacts

Public ContactSameer Shinde

Government Medical college, Maharashtra

sudhir.medhekar@gmail.com9820321430

Outcome results

None listed

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