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

A single blinded, single centered study, to assess the efficacy of investigational product for its moisturization on healthy human female subjects. - None

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003803

Enrollment

Registered

2013-07-05

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: Lakme Skin Gloss Intense Moisturizing Cream: Instrumental evaluation and dermatological assessment,pre product application (T0), 30 minutes (T1), 2 hours (T2), 4 hours (T3) post product

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactMs Vaishali Dhavan

KET Scientific Research Centre

vaishali@kelkarcosmetology.com02225639644

Outcome results