A Randomized, Double-blinded, Placebo Controlled, Monocentric Study to Evaluate the Anti-ageing a… (NCT04276753) | Clinical Trial Compass
CompletedNot Applicable
A Randomized, Double-blinded, Placebo Controlled, Monocentric Study to Evaluate the Anti-ageing and Skin Brightening Benefit of the Test Product in Healthy Female Subjects
India26 participantsStarted 2020-09-03
Plain-language summary
Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Aging caused by the genes is inherited and is called intrinsic (internal) aging. The other type of aging is known as extrinsic (external) aging and is caused by environmental factors, such as exposure to the sun's rays.
Skin ageing is mainly characterized by -
1. Decrease in thickness, firmness \& elasticity of skin which results in wrinkles.
2. Reduction in antioxidant capacities.
3. Formation of spider veins and dark circles under the eyes. This study is proposed to evaluate skin antiaging efficacy along with the brightening attributes on face by visual assessment by Dermatologist, image analysis using VISIA CR, skin elasticity by Cutometer (MPA580) Hydration by Corneometer and skin texture by Antera 3 D and skin lightening/fairness by spectrophotometer, water barrier function by TEWL and to skin pH level by pH meter.
Who can participate
Age range
35 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
* Subjects in the age group of 35-50 years (both ages inclusive).
* Subject with Fitzpatrick skin types III to V (ITA to be recorded at forehead and flexor forearm)
* Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
* Subjects with normal to dry skin type (corneometer reading upto 35)
* Subjects with mild to moderate fine lines and wrinkles in periorbital area (Crow's feet-under eye) \& forehead (Refer annexure 3 for photonumerical scale)
* Subjects with minimum one spot with width ≥3 mm
* Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
* Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
* Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test product.
* Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
* Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
* Subjects willing to give a voluntary written informed consent, photograph…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the investigational product for skin aging benefits
Timeframe: 8 weeks
2
Evaluate the investigational product for skin brightening benefits