A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel (NCT06123572) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel
India44 participantsStarted 2023-09-14
Plain-language summary
This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel.
Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)
Who can participate
Age range
35 Years – 55 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
. Age: 35 to 55 years (both inclusive) at the time of consent.
. Sex: Healthy and non-pregnant/non-lactating females.
. Subjects who are generally in good health as determined by/form recent medical history.
. Female of child bearing capacity must have a self-reported negative pregnancy test.
. Subjects having mild to moderate crows' feet wrinkles.
. Subjects having a score of at least "mild skin aging" based on PGA at screening visit.
. Subjects having a score of at least "mild skin pigmentation" based on Skin Pigmentation Score at screening visit.
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
Change in Skin Elasticity
Timeframe: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
2
Change in CIE L*, a* b*, ITA (Individual Topography Angle), skin brightness, skin pigmentation
Timeframe: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
3
Change in Skin Glow
Timeframe: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
4
Change in crow's feet area wrinkles, fine lines
Timeframe: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
5
Change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin
Timeframe: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
6
Change in facial photographs
Timeframe: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products
. Subjects having Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
Exclusion criteria
. Subjects having a history of allergy or sensitivity to the test treatments ingredients.
. Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne or any other) that could interfere with the outcome of the study as determined by the Investigator.
. Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
. Subjects who have applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
. Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
. Subjects having a history of alcohol or drug addiction.
. Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
. Subjects who have applied any topical retinoids or glutathione within 2 weeks of the screening visit or anticipates having to use at any point during the study.
7
Change in wrinkles, fine lines and pores
Timeframe: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products