Anti-Ageing study
- Registration Number
- CTRI/2022/01/039627
- Lead Sponsor
- ITC Life Sciences Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 151
1.Subject is willing to give a written informed consent and come for regular observations.
2.Subject is a healthy adult (male or female), in the age range of 35 and 60 years.
3.Subject identified for Wrinkles, has at least 2 and preferably >4-5 prominent wrinkles on crow feet area, forehead, undereye, Throat/ Neck and D�©colletage.
4.Subject identified for Post Inflammatory Hyperpigmentation (Dark Spots), has at least 2 and preferably >4-5 hyper pigmentary spots on face that are freckles / age spots/ post inflammatory hyperpigmentation spots like post acne marks/ Seborrheic dermatitis/ or marks other than melasma/ chloasma or nevi.
5.Atleast 20 subjects in each treatment group with prominent Undereye dark circles
6.Atleast 20 subjects in each treatment group with sagging skin under the chin, throat,
7.Subject has not participated in a similar clinical investigation in the past three months.
8.Subject has not used any topical fairness product on face or undergone a treatment such as facials, packs, bleaching etc on face since the last 2 weeks. In case of having used fairness product in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face.
9.Subject is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs etc either at home or at parlour during the entire study duration.
10.Subject with no skin sensitivity symptoms to the investigational product during the skin sensitivity test.
11.Female subjects of reproductive age group willing to undergo UPT at the time of screening visit
1.Subject with a known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or their ingredients including fragrance.
2.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.
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 with excessive facial hair or scars, which could interfere with evaluation.
5.Subject with a history of having used a similar product, less than 1 week prior to the scheduled study commencement.
6.Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.
7.Subjects viewed by the investigator as not being able to complete the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Significant reduction of Wrinkles, Fine lines and Post Inflammatory Hyperpigmentation (Dark Spots) compared to Baseline at any time point of the study with no significant increase thereafter. <br/ ><br>2.Significant moisturization longevity compared to untreated site and Baseline. <br/ ><br>3.Significant improvement in skin firmness (elasticity) compared to Untreated siteTimepoint: 12 weeks of product use
- Secondary Outcome Measures
Name Time Method 1.Significant improvement in deeper moisturization compared to Untreated site. <br/ ><br>2.Significant improvement in skin Clarity, Even Tone and Hydration compared to Baseline at any time point of the study with no significant drop thereafter. <br/ ><br>3.No discomfort or allergic reaction elicited by the investigational productTimepoint: 12 weeks of product use