Anti skin aging efficacy study
- Registration Number
- CTRI/2017/01/007731
- Lead Sponsor
- ITC Life Science and Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
•Subject is willing to give a written informed consent
•Subject is a healthy adult (male or female) in the age range of 35- 60 years
•Subject has a wrinkle score between 2 and 4 (moderate/ medium wrinkles) as per the photonumeric scale
•Subject has at least 2 dark spots on face that are age spots /lentigines marks other than Mealsma or Chloasma
•In case of having used fairness product in the near past Subject is willing to undergo a wash out period of 1 week, wherein they would abstain from applying any product other than the provided cleanser on face.
•Subject who is willing to comply with the study protocol and abide by the study restrictions such as refraining from using cosmetic or medicinal or ayurvedic or 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 cream during the entire study course and visiting the centre for regular follow up visits.
•Female subjects of reproductive age group willing to undergo UPT at time of screening visit.
•Female subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.
•Subject with a known history or present condition of allergic response to any cosmetic products, toiletries or their ingredients including fragrance.
•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
•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.
•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.
•Subject with excessive facial hair or scars, which could interfere with evaluation.
•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 To evaluate the safety and efficacy of the investigational products (IP) in reducing the facial wrinkles and fine lines in comparison to the baseline and a reference productTimepoint: Week 0, week 2, week 4, week 6, week 8, week 10 & week 12
- Secondary Outcome Measures
Name Time Method To monitor the safety of long term use of anti-skin aging formulations on all skin types. <br/ ><br>To evaluate the overall changes in skin condition upon usage of the IP in comparison to baseline and a reference productTimepoint: Week 0, week 2, week 4, week 6, week 8, week 10 & week 12