MedPath

To evaluate the dermatological safety of hair oil and shampoo on women with sensitive scalp conditions.

Phase 2
Completed
Registration Number
CTRI/2018/01/011454
Lead Sponsor
Dabur India Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
35
Inclusion Criteria

1) Volunteer in generally in good health.

2) Volunteer with sensitive scalp condition.

3) Healthy female volunteer between 19 to 35 years of age (both inclusive)

4) Volunteer willing to give a written informed consent and come for regular observation.

5) The volunteer has not participated in a similar clinical investigation in the same past four weeks.

Exclusion Criteria

1) A known history or present condition of an 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) Pregnant or lactating.

5) Volunteer viewed by the investigator as not being able to complete the study or participating in another study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the safety of the Product Regimen (shampoo & oil) on healthy human female subjects with sensitive scalp condition.Timepoint: Screening, week 0, week 2 and week 4.
Secondary Outcome Measures
NameTimeMethod
To evaluate overall safety of the subject throughout the study.Timepoint: Screening, week 0, week 2 and week 4.
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