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To check irritation potential of the given cosmetic samples-Patch test.

Single application, single centered, open label, closed patch test to evaluate the safety of cosmetic formulations on 26 healthy human subjects representing varied skin types.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008703
Enrollment
26
Registered
2017-05-31
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

Intervention1: 1. 272/2016/332 (A) Keratin Shampoo 2. 272/2016/332 (B) Quinoa Smooth Shampoo 3. 272/2016/332 (C) Color Lock Shampoo 4. 272/2016/332 (D) Avocado N

Sponsors

Godrej Consumer Product Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: .Volunteer (female and male) in generally good health. 2.Volunteer between the ages of 18 and 50 years. 3.Volunteer has not participated in a similar clinical studies in the past three months. 4.Volunteer willing to give a written Informed Consent, also agrees under audio-video consenting procedures and should come for regular three visits after patch application. 5.Volunteer with fair skin will be preferred. 6.Volunteer with clear back. 7.UPT test should be negative for female volunteer at the time of screening.

Exclusion criteria

Exclusion criteria: 1.Known history or present condition of allergic response to any cosmetic products. 2.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings. 3.Medications (e.g. steroids or antihistamines), which would compromise the study. 4.Under the influence of alcohol. 5.Pregnant or lactating women. 6.Any history of underlying uncontrolled medical illness including diabetes, liver disease or any other serious medical illness 7.Volunteers participating in any other cosmetics related clinical trials or any other clinical trial. 8.Hypersensitivity to any of the tested products. 9.Use of Hormonal Contraceptives either Oral or Implants. 10.Any other

Design outcomes

Primary

MeasureTime frame
Evaluation of Skin irritation potential (occurrence of Erythema, Oedema) w.r.t. the investigational products.Timepoint: Day 1- Screening, Day 2 Patch application, Day 3 - Patch removal(0 hr observation), Day 4- 24hr Observation.—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactDr Sudhir Medhekar

sanity lifesciences pvt. ltd

sudhir.medhekar@gmail.com

Outcome results

None listed

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