To evaluate the efficacy of cosmetic products in skin lightening of healthy human volunteers.
- Registration Number
- CTRI/2018/11/016259
- Lead Sponsor
- ITC Life Sciences Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Subject is willing to give a written informed consent
2.Subject is a healthy adult female in the age range of 25 - 60 years
3.At least 45 subjects in the age group of 40-48 yrs. (Perimenopausal phase) , 30 subjects in the age group of 49-60 yrs. (Menopausal phase).
4.At least 30 subjects having a wrinkle score between 2 and 4 (moderate/ medium wrinkles) as per the photonumeric scale
5.At least 30 women (mothers of 2-8yr old children) with post inflammatory hyperpigmentation marks on face (post acne / estrogen imbalance related marks). Subjects with mild melasma can be taken in the study.
6.Subject who is willing to comply with the study protocol and abide by the study restrictions such as refraining from using cosmetic/ medicinal/ ayurvedic/ natural products on face and also willing to abstain from undergoing any facial treatments such as facial masks, packs, waxing, threading etc. either at home or at parlour other than the provided product during the entire study course.
7.Subjects willing to visit the centre as per the specified schedule for regular follow up visits.
8.Subjects willing to undergo UPT at the time of screening visit.
1.Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy (as disclosed voluntarily) during the study course.
2.Subject with a known history or present condition of allergic response to any cosmetic products, toiletries or their ingredients including fragrance.
3.Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.
4.Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti-acne medication) within past 4 weeks or any topical facial medication within 2 weeks before the start of the study, which could compromise the study.
5.Subject has not participated in a similar clinical investigation in the past three months or applied skin lightening product on face or undergone a treatment like facial packs, bleaching in the past two weeks.
6.Subject with excessive facial hair or scars, which could interfere with evaluation.
7.Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dermatological safety, skin lightening and anti- aging efficacy of the investigational products (IP) over baseline and the reference products.Timepoint: Approximately 8 weeks
- Secondary Outcome Measures
Name Time Method Overall changes in skin conditions on usage of the IP in comparison to baseline and the reference productTimepoint: Approximately 8 weeks