To evaluate dermatological safety of shampoo.

To evaluate the shampoo formulations for their irritation potential on the scalp of healthy human subjects.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011405

Enrollment

115

Registered

2018-01-18

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: Product E: The subjects were advised to use shampoo on daily basis and visit for evaluation on day 0, day 5, day 10 and day 20. Vatika Smooth & Shine Shampoo with Henna cream conditioni

Eligibility

Inclusion criteria

Inclusion criteria: 1.Female subject in generally good health. 2.Subject is between 18 to 40 years of age group. 3.Subject having normal hair. 4.Subjects willing to give a written informed consent and come for regular follow up.

Exclusion criteria

Exclusion criteria: 1.Subject has a known history or present condition of allergic response to any cosmetic products or fragrance 2.Subject has skin disease (e.g. Psoriasis, Atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings 3.Subject is on regular medications (e.g. steroids or antihistamines), which would compromise the study. 4.Subject is currently pregnant or breastfeeding. 5.Currently or has been involved in another such clinical investigation within the last 3 months. 6.Subjects viewed by the investigator as not being able to complete the study.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of shampoo on repetitive usage on healthy human subjectsTimepoint: Day1,Day5, Day10, Day20	—

Secondary

Measure	Time frame
To evaluate overall safety of the subject throughout the studyTimepoint: Day1, Day5, Day10, Day20	—

Countries

India

Contacts

Public ContactMamohan Sharma

Dabur India Ltd.

manmohan.sharma@dabur.com01203378591

Outcome results