MedPath

To assess the efficacy of investigational product for its moisturization on healthy human female subjects

Phase 2
Registration Number
CTRI/2013/07/003803
Lead Sponsor
Hindustan Unilever Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

1.Volunteer in generally good health.

2.Volunteer between the age group of 20 and 40 years.

3.Volunteer with Normal to dry skin type.

4.Volunteer has not participated in a similar clinical investigation in the past four weeks

5.Volunteer willing to abstain from using any cosmetic product on face, besides the provided product during the entire study course.

6.Volunteer willing to visit the site at specified frequencies for periodic evaluations.

7.Volunteer willing to comply with study specific requirements.

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

Exclusion Criteria

1.A known history or present condition of allergic response to any cosmetic products.

2.Volunteer with known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies / infections.

3.Volunteer under any dermatological treatment / prescribed medications.

4.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.

5.On medications (e.g. steroids or antihistamines), which would compromise the study.

6.Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.

7.Volunteer; pregnant or nursing.

8.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 assess efficacy of investigational product for its moisturization on healthy human female subjectsTimepoint: at pre product application (T0), 30 minutes (T1), 2 hours (T2), 4 hours (T3) post product application and after 24 hours (T4)post product application and 1week (T5) post product usage
Secondary Outcome Measures
NameTimeMethod
to assess irritation potential on the healthy human female subjectsTimepoint: assessment for irritation will be carried out at pre product application (T0), 30 minutes (T1), 2 hours (T2), 4 hours (T3) post product application and after 24 hours (T4) and 1week (T5) of product usage
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