A Proof of Science, Dose-Response Study to Evaluate the Safety, Efficacy of Different Dosages of Test Treatments

Healthy Clinical Trial

Official title: A Proof of Science Clinical Study With Randomized, Four Arm, Comparative, Single-Blind, Within the Arm - Dose-Response Study to Evaluate the Safety, Efficacy of Different Collagen Peptide Containing Test Treatments in Adult Human Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

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.

There are four different test treatments as mentioned below will be tested during study.

• Test Treatment A: VEGCOL™️ (Veg Collagen Peptide)

• Test Treatment B: PROCOL (Bovine Collagen Peptide)

• Test Treatment C: AQUACOL (Fish/Marine Collagen Peptide)

• Test Treatment D: CALCOL (Chicken Collagen Peptide) Mode of Usage: 1 scoop/sachet of daily Route of Administration: Oral Administration with a glassful (approx. 250 mL) of water.

Considering proof of science study, a sufficient number of adult subjects with an age group of 30 - 50 years old (i) having mild to moderate crows' feet wrinkles near to eye area and (ii) mild to moderate joints pain, swelling, stiffness and decreased range of motion (iii) having complaints of hair fall, decreased hair growth, brittle nails will be recruited/enrolled.

In Bovine Arm, out of 66 subjects, a few subjects with osteoarthritis patients having present complaints of pain and stiffness in joints will be enrolled.

The collagen peptides effects of all 4 variants will be evaluated in enrolled subjects with mild to moderate acne.

The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits.

• Visit 01 (Day -04): Screening, Baseline evaluations

• Visit 02 (Day 01): Enrolment, Hair Growth Rate measurement, Evaluations

• Visit 03 (Day 10): Treatment Period, Evaluations

• Visit 04 (Day 30): Treatment Period, Evaluations

• Visit 05 (Day 57): Treatment Period, Evaluations, Tattoo, Hair growth measurement

• Visit 06 (Day 60): Evaluations, End of Study Visit

Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be telephonically contacted by recruiting department prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) not to wear any facial makeup during study visits to the facility. The study will be conducted in four different groups considering four different arms of test treatments.

Assessment of safety and efficacy parameters will be done before test treatment usage on Day 1, and will be compared with after test treatments usage on Day 10 (+2 Days), Day 30 (+2 Days), and Day 60 (+2 Days) within treatments and between treatments, between three dosages as listed-below.

• Skin Elasticity: DermaLab®Combo (Right cheek)

• Deep Skin Hydration: MoitureMeterEPiD (Right cheek)

• Skin Moisture for Skin Barrier Function: Vapometer (Right Cheek)

• Crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness: Visioscan (C+K Instrument)

• Improvement in Glogau Skin Age : Dermatological evaluation

• Improvement in PGA Dermatologist Scoring using Griffiths Scale - Skin dryness, redness, fine wrinkles/lines, coarse wrinkling/lines, laxity, roughness, and sallowness : Dermatological evaluation

• Change of the PGA score for assessment of the signs of brittle nails

• Change of the PGA score for assessment of Acne

• Hair Strength: Hair Pull test

• Hair Fall Reduction: 60-second hair count (Hair Combing Method)

• Hair Growth, Thickness, Density: CASLite Nova (Phototrichogram)

• A:T Ratio (Hair Growth Cycle): Pluck Test - Trichogram (Microscopic Evaluation)

• Hight, Weight, BMI - Anthropometry

• Leeds Sleep Evaluation Questionnaire (LSEQ) - Deep and Sound Sleep

• Hedonic Questionnaires - about product perception and consumer feedback. - Skin elasticity, suppleness, deep and sound sleep, digestion and gut health, joint health, nail, and hair health

• Change in Pain According to VAS (0-10 cm) for arthritis complaints

• Consumption of Rescue Medication for osteoarthritis patients/subjects

• Change in muscles strength - as assessed by the sum of the handgrip, elbow flexion and extension, and knee flexion and extension strength by the dynamometer

• Digital Photographs: Facial photographs [Left, Center, Right] and Nails photographs before test treatment usage and after test treatment usage. ;

Related Conditions & MeSH terms

• Brittle Nails
• Healthy
• Mild to Moderate Acne
• Osteoarthritis, Knee

• NCT number: NCT05613660
• Study type: Interventional
• Source: NovoBliss Research Pvt Ltd
• Status: Completed
• Phase: N/A
• Start date: January 11, 2023
• Completion date: June 30, 2023