A clinical study to evaluate safety and Effectiveness of the Elure advanced skin whitening products (Advanced whitening lotion and Advanced whitening night cream) in imparting skin fairness on healthy human volunteers.

A prospective phase II, open label, monocentric, single arm clinical study on safety and Efficacy of the Elure advanced skin whitening products (Advanced whitening lotion and Advanced whitening night cream) in imparting skin fairness on healthy human volunteers with Skin type III, IV and V.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/01/002363

Enrollment

Registered

2012-01-23

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: Investigational Product Elure advanced whitening kit containing â?¢ Advanced whitening lotion (active melanozyme and bio-activator) â?¢ Advanced whitening night cream (active melanozyme

Eligibility

Inclusion criteria

Inclusion criteria: Female subjects in generally good health. Subject can read and comprehend with the English informed consent form. Subjects of skin types III, IV, and V. Subjects age group 18 - 60 years Subjects willing to give a written informed consent and come for a regular follow up. Subject willing to abide by and comply with the study protocol Subject has not participated in a similar investigation in the past four weeks. Subjects having post inflammatory hyperpigmentation, freckles, pigmented demarcation lines, and uneven tone skin will also be included. The subject will be enrolled after the sensitivity test is negative for all the sites

Exclusion criteria

Exclusion criteria: A known history or present condition of allergic response to any cosmetic products. Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings. Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study. Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy. Subjects not willing to discontinue other fairness/whitening/ brightening creams including vitamin A derivatives. Subjects who are pregnant, lactating or nursing. Hypersensitivity to any component of the tested products. History of intense sun exposure. Chronic illness which may influence the cutaneous state. Subject participating in any other cosmetic or therapeutic trial. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness. Subject having any sensitive reaction to the investigational product- Skin Sensitivity test.

Design outcomes

Primary

Measure	Time frame
1.Improvement in whitening property of skin in comparison to baseline. 2.Improvement in melanin values in Mexameter readings in comparison to baseline readings. 3.Improvement in L value in Chromameter readings in comparison to baseline readings. Timepoint: Day 1, Day 15, Day 28, Day 56, Day 84	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS Clinical Research Pvt Ltd.,

mukta.sachdev@mscr.in080-40917253

Outcome results