A clinical study to evaluate the safety & efficacy of test product in Healthy Female subjects
- Registration Number
- CTRI/2023/06/053620
- Lead Sponsor
- DPKA Universal Consumer Venture Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
1) Age: 21 to 50 years (both inclusive) old at the time of consent.
2) Sex: Healthy human non-pregnant/non-lactating females.
3) Frequent users of international brands.
4) Females of childbearing potential must have a self-reported negative urine pregnancy test.
5) Subjects are generally in good general health as determined from recent medical history.
6) The subject is willing and able to follow the study directions, participate in the study,
returning for all specified visits.
7) The subject must be able to understand and provide written informed consent to participate
in the study.
Subjects must not be enrolled in the study if they meet any one of the following criteria:
1) Subject with known allergy or sensitization to cosmetic products.
2) The subject has clinically significant skin disease, which may contraindicate participation,
including psoriasis, eczema, Skin cancer or other skin pathology.
3) Medication which may affect skin response and/or past medical history.
4) Individuals with active (flaring) disease or chronic skin allergies (atopic dermatitis/eczema)
or those who have recently undergone treatment for skin cancer (within the last 12 months)
in the area of testing on the forehead, nose and the cheeks.
5) Female volunteers who have started a new hormonal birth control agent or switched to a
hormonal birth control agent within the past 60 days.
6) Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or
plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin,
dermal fillers, collagen or other similar cosmetic procedure.
7) Individuals who are currently using or during the past 14 days have used a retinoid such as
tretinoin, adapalene, or retinol containing agents or a hydroquinone containing agent.
8) Individuals who have used mineral clay masks on their face within the last 14 days.
9) Individuals who have been on any topical prescribed medications for the past 2 weeks.
10) An individual who has a medical condition or is taking or has taken a medication which, in
the Investigator’s judgment, makes the subject ineligible or places the subject at undue
risk.
11) Participation in other clinical studies simultaneously.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in skin hydration <br/ ><br>2. Change in Skin Radiance <br/ ><br>3. Change in Sebum Secretion <br/ ><br>4. Change in number of pores, visible pores area, & clogged pores <br/ ><br>5. Improvement in visible pores areaTimepoint: From Baseline to Day 01 & Day 03
- Secondary Outcome Measures
Name Time Method Change in facial PhotographsTimepoint: From Baseline to Day 01;To evaluate the product effectiveness in terms of subject response <br/ ><br>indexTimepoint: From Baseline to Day 01 & Day 03