To assess the efficacy of Intimate Lightening Cream in healthy adult human female subjects.
- Registration Number
- CTRI/2022/09/045821
- Lead Sponsor
- Arbro Pharmaceutical Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must meet all of the following criteria in order to be included in the study.
1 Subject in generally good health.
2 Subject between the age group of 18 and 45 years.
3 Subject has not participated in a similar clinical investigation in the past four weeks.
4 Subject willing to abstain from using any product, besides the provided product during the entire study course.
5 Subject willing to visit the site at specified frequencies for periodic evaluations.
6 Subject willing to comply with study specific requirements.
7 Subject willing to give a written informed consent and come for regular observation.
Subjects meeting any of the following criteria must be excluded from enrolment in the study.
1 A known history or present condition of allergic response to any Cosmetic products.
2 Subject with known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies infections.
3 Subject 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 Any cutaneous conditions on the test site (scars, moles, papules etc.)
6 On medications (e.g. steroids or antihistamines), which would compromise the study.
7 Currently or has been undergoing dermatologist treatments or procedures within the last 1 month.
8 Subject 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
Name Time Method To evaluate the effects of a cosmetic product for:- <br/ ><br>Hydration and Melanin or erythemaTimepoint: Day 0, Day 5, Day 10 and Day 15
- Secondary Outcome Measures
Name Time Method Measurement of skin hydration effects by Corneometer <br/ ><br>Measurement of skin melanin and erythema effects by Mexameter.Timepoint: Day 0, Day 5, Day 10 and Day 15