A Proof of Science, Dose-Response Study to Evaluate the Safety, Efficacy of Different Dosages of … (NCT05613660) | Clinical Trial Compass
CompletedNot Applicable
A Proof of Science, Dose-Response Study to Evaluate the Safety, Efficacy of Different Dosages of Test Treatments
India264 participantsStarted 2023-01-11
Plain-language summary
A proof of science clinical study with randomized, four-arm, comparative, single-blind, within the arm - Dose-Response Study to evaluate the safety and efficacy of different collagen peptide-containing test treatments in adult human subjects.
The dose-response will be evaluated for the effectiveness of each test treatment in three different dosages that is 2.5 g Versus 5 g Versus 10 g.
22 subjects will be enrolled per dose per test treatment to complete 20 subjects per dose per test treatment.
Who can participate
Age range
30 Years – 50 Years
Sex
ALL
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: 30 to 50 years (both inclusive) at the time of consent.
. Sex: Healthy non-pregnant/non-lactating females and Males.
. Female of childbearing potential must have a reported negative pregnancy during screening and end of the study.
. Subject is generally in good health.
. Subject has mild to moderate crows' feet wrinkles.
. Subject has mild to moderate joints pain, swelling, stiffness and decreased range of motion.
. Subject has a score of at least "mild skin aging" based on PGA 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 the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
2
Change in Skin Elasticity
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
3
Change in Skin Hydration
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
4
Change in Hair Thickness and Density
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
5
Change in Hair Fall
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
6
Change in Body Weight and BMI
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
7
Change in Joints Pain using VAS (0-10 cm) scoring evaluated by trained study staff
. Subject has Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
Exclusion criteria
. Subject has a history of allergy or sensitivity to the test treatments ingredients.
. Subject who has a history of allergy with products containing Fish, Bovine, Chicken, broccoli and carrots.
. Subject who has 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.
. Subject has 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.
. Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
. Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
. Subject has a history of prior use of hair growth treatment within 3 months.
. Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
8
Change in muscles strength
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
9
To assess the effect of test treatment in terms of change in hair growth on the scalp
Timeframe: Baseline visit i.e. during Visit 01 (04 days before Day 01) and Visit 02 (Day01) before application to Visit 05 (Day 57) and Visit 06 (Day 60)