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 range30 Years – 50 Years
SexALL
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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.
✓. 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.
✕
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
Timeframe: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
. 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).
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)