A skin whitening efficacy and safety study in adult, human male subjects
- Registration Number
- CTRI/2011/07/001880
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1)Age:18-45 years; both inclusive
2)Sex:Male
3)Volunteer is in good physical health as determined by the Investigator/Co-investigator.
4)Volunteer is willing and able to follow the study directions, to participate in the study, returning for all specified visits, and to apply the product only to the part of the areas as per instructions.
5)Volunteers, who are willing to avoid sun bathing, swimming, prolong sun exposure or artificial UV rays during the study.
6)Able to communicate effectively with study personnel.
7)Able to understand and provide written informed consent to participate in the study.
1)Volunteers with acne, skin infections over face, widespread active dermatitis or dermatitis on test area.
2)Volunteers with allergies to cosmetics, moisturizers, and whitening/bleaching agents.
3)Volunteer who has sunburned, chapped, or irritated skin or open wounds on test sites.
4)Volunteer who are willing to continue any other personal care products containing whitening/bleaching properties during study period.
5)Volunteer who are swimmers.
6)History or presence of Diabetes.
7)History of skin cancer or treatment for any type of cancer within the last 2 years.
8)Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, acne, eczema, atopic dermatitis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. porphyria).
9)A positive test result for HIV antibody.
10)Participation in a study involving the same test area within the last 30 days.
11)Volunteer who has a condition or is taking or has taken a medication which, in the investigatorâ??s judgment, makes the volunteer ineligible or places the volunteer at undue risk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical Evaluation using skin fairness score <br/ ><br>2. Self Evaluation questionnaire to evaluate the product efficacy and sensorial properties <br/ ><br>3. Assessment of skin fairness using Minolta ChromameterTimepoint: 1. Baseline visit <br/ ><br>2. Week 1 <br/ ><br>3. Week 2 <br/ ><br>4. Week 4 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Clinical evaluation for tolerance and subject compliance to therapyTimepoint: Week 1, 2, 3 and 4