Efficacy Evaluation Of Skin Fairness Creams On Healthy Human Volunteers
- Registration Number
- CTRI/2011/11/002134
- Lead Sponsor
- ITC Research and Development centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 320
Subjects willing to give a written informed consent and come for regular follow up.
Female subjects in generally good health, in the age group of 18 - 45 years.
Subjects having Chromameter L value between 40-60 on cheeks and L value at least 3 units higher than the cheeks on upper volar bicep region.
Subject, who get Sun exposure for atleast 20-40 mins per day.
At least 5 subjects under each treatment group having acne prone skin.
At least 5 subjects under each treatment group having few hyper-pigmentation spots on face like solar lentigines and /or post acne dark spots other than melasma/ nevi etc.
Subjects willing to abstain from using other cosmetic/ medicinal/ ayurvedic/ natural products on face during the study course.
A known history or present condition of Allergic response to any cosmetic product
Subject having skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings
Subjects having Melasma/ Chloasma/ Nevi/ Post inflammatory hyperpigmentation marks and other forms of severe photo damage at the site of evaluation (Except Hyper-pigmentary age spots/ small post acne marks)
Subjects on medications (e.g. steroids or antihistamines), which could compromise the study results
Pregnant/ nursing females
Subjects who are involved in physical labor work
Subjects with tattoos, dense hair, moles, warts on face and volar forearms at the site of evaluation.
Subjects with known sensitivity to sun, sunscreens/ cosmetics/ fragrances
Subjects having participated in a similar investigation in the past four
weeks
Subjects having used a similar product for the last two weeks (Washout period)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)To evaluate the efficacy of fairness cream formulations in conferring skin fairness, radiance and glow, moisturization, softness, smoothness and healthy appearance in comparison to baseline and to other investigational products.2)To evaluate the efficacy of fairness cream formulations in reducing Sun induced tanning and associated photodamage in terms of dark spots and wrinkling in comparison to baseline and to other investigational products.Timepoint: 6 Weeks
- Secondary Outcome Measures
Name Time Method ?To evaluate the safety of fairness cream formulations on all skin types including acne prone skin. <br/ ><br> <br/ ><br>?To evaluate the efficacy of fairness cream formulations in conferring even tone, clear skin, young appearing skin in comparison to baseline, placebo and other investigational products.Timepoint: 6 Weeks