A study to check the skin safety and effect of SkinQGlow Bright Wonder Mask in Healthy Human Subjects withadequate representation of varied skin types (Normal, Oily,Dry, Combined, and Sensitive skin)
- Registration Number
- CTRI/2022/08/044867
- Lead Sponsor
- Health Q Life Sciences Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
1) Age: 18 to 55 years (both inclusive) old at the time of consent.
2) Sex: Healthy adult males and non-pregnant/non-lactating females.
3) Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
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) Subjects with visibly tanned skin determine by a dermatologist or dermatologist trained evaluator.
7) The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
8) The subjects who have not done any facial treatment, or any herbal facial, tanning removal for more than 30 days and who regularly use tanning removal products.
9) The subject is willing and able to follow the study directions, and participate in the study.
10)The subject must be able to understand and provide written informed consent to participate in the study.
1) Subject with known allergy or sensitization to product ingredients such as niacinamide, glycolic acid, Liquorice, vitamin c, mulberries, purple brazilian clay or any other ingredients.
2) The subject had a facial or chemical peeling or derma abrasion | roller etc. in the last 4 weeks.
3) The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
4) Be wearing any facial makeup, including false eyelashes, on the day of the study visit.
5) Be using any skin lightening | brightening or tanning removal product within 15 days and on the day of the study visit.
6) Medication which may affect skin response and/or past medical history.
7) The subject has a history of diabetes
8) The subject has a history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
9) The subject suffering from any active clinically significant skin diseases which may contraindicate.
10) The subject has a history of any skin diseases including eczema, atopic dermatitis etc.
11) Subject with self-reported immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus.
12) Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) or analgesics (including aspirin or other over-the-counter analgesics) on the days of the study.
13) An individual who has a medical condition or is taking or has taken a medication which, in the Investigatorââ?¬•s judgment, makes the subject ineligible or places the subject at undue risk.
14) Participation in other clinical studies simultaneously
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the instant change in skin colour, and tone with a single application of the test product <br/ ><br>2. To assess the instant change in skin surface i.e. smoothness, roughness, scaliness, wrinkles <br/ ><br>3. To assess the instant change in skin pores in a single applicationTimepoint: From the baseline on Day 01 before application and after product removal at 5 mins and 15 mins On Day 01
- Secondary Outcome Measures
Name Time Method