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

NCT05613660 | Completed

• 1 other identifier: NB220031-COL
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild to Moderate Acne; Stiffness of Joint, Nec, Involving Ankle and Foot in MDR24_1; Other Specified Diseases of Hair and Hair Follicles; Brittle Nails; Osteoarthritis, Knee; Healthy

Keywords

Acne, Wrinkles, Joints pain, brittle nails, hair fall

Outcome Measures

Primary Outcomes (9)

• Change in the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness

  To evaluate the effectiveness of the test treatments for change in the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness using Visioscan® VC 20 Plus after 8 weeks of treatment, between treatments, between three different dosages and within a treatment

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Skin Elasticity

  To evaluate the effectiveness of the test treatments in skin elasticity using DermaLab®Combo or equivalent (Right cheek) after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Skin Hydration

  To evaluate the effectiveness of the test treatments in skin hydration using MoitureMeterEPiD (Right cheek) after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Hair Thickness and Density

  To evaluate the effectiveness of the test treatments for change in Hair Thickness and Density in using CASLiteNova through Phototrichogram after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Hair Fall

  To evaluate the effectiveness of the test treatments for change in hair fall using a 60-second hair count (Hair Combing Method) after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Body Weight and BMI

  To evaluate the effectiveness of the test treatments for change in body weight in Kg and Body Mass Index (BMI) Kg/m2 after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Joints Pain using VAS (0-10 cm) scoring evaluated by trained study staff

  To evaluate the effectiveness of the test treatments for change in Joints Pain using VAS (0-10 cm) scoring evaluated by trained study staff after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in muscles strength

  To evaluate the effectiveness of the test treatments for change in muscle strength as assessed by the sum of the handgrip, elbow flexion, and extension, and knee flexion and extension strength evaluated by trained study staff after 8 weeks of treatment, between treatments, between three different dosages, and within a treatment

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• To assess the effect of test treatment in terms of change in hair growth on the scalp

  Hair growth rate (µm/day) will be measured by using data of hair growth from Visit 01 and Visit 02 for baseline reading and from Visit 05 and Visit 06 for post-treatment reading. Note: Hair growth rate (μm/day) will be measured by using data of hair growth from Visit 01 and Visit 02 for baseline reading and from Visit 05 and Visit 06 for post-treatment reading

  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)

Secondary Outcomes (10)

• Change in Physician Global Assessment (PGA) scoring - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Glogau Skin Age

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change on hair strength by Pull test

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Physician Global Assessment (PGA) score for assessment of the signs of brittle nails, surface roughness, raggedness, and peeling

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

• Change in Sleep Quality using Leeds Sleep Evaluation Questionnaires (LSEQ)

  Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)

Study Arms (4)

VEGCOL™️ (Veg Collagen Peptide)

EXPERIMENTAL

Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water VEGCOL helps in providing the necessary nutrition needed for the body to produce collagen. Vegan collagen gives a lighter feel on consumption compared to any other collagen and increases the elasticity of the skin and makes skin supple. VEGCOL has more amino acids than animal derived Collagen which makes it very ideal to consume not only in Vegetarian populated countries like in India but around the world. Pepsin, a digestive enzyme, is added to help structure the building blocks into collagen molecules with the exact structure of human collagen.

Dietary Supplement: Veg Collagen Peptide

PROCOL (Bovine Collagen Peptide)

EXPERIMENTAL

Bovine collagen is a naturally occurring protein present in the connective tissue, bones, cartilage, and hides of cows. Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water.

Dietary Supplement: Bovine Collagen Peptide

AQUACOL (Fish | Marine Collagen Peptide)

EXPERIMENTAL

Marine Collagen is made from Fish Skin which delays the signs of aging such as wrinkles, Joint issues and weakness. Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water.

Dietary Supplement: Fish | Marine Collagen Peptide

CALCOL (Chicken Collagen Peptide)

EXPERIMENTAL

Chicken collagen is used to treat joint pain associated with many types of arthritis and surgery, as well as back pain, neck pain, and pain following injury. Chicken collagen works by causing participants' body to produce substances that fight inflammation and pain. It also contains chondroitin and glucosamine, two compounds that help rebuild cartilage. That's why chicken collagen can provide some amazing benefits for participants' gut, immune system, skin, and more. Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water.

Dietary Supplement: Chicken Collagen Peptide

Interventions

Veg Collagen Peptide DIETARY_SUPPLEMENT

Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water

Also known as: VEGCOL™️

VEGCOL™️ (Veg Collagen Peptide)

Bovine Collagen Peptide DIETARY_SUPPLEMENT

Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water

Also known as: PROCOL

PROCOL (Bovine Collagen Peptide)

Fish | Marine Collagen Peptide DIETARY_SUPPLEMENT

Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water

Also known as: AQUACOL

AQUACOL (Fish | Marine Collagen Peptide)

Chicken Collagen Peptide DIETARY_SUPPLEMENT

Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water

Also known as: CALCOL

CALCOL (Chicken Collagen Peptide)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subject having complaints of hair fall and decreased hair growth.
• The subject self-declare nonpathological thin, dry, and brittle hair and nails.
• Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
• Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
• Subject is able to forgo changes in baseline medications and nutritional supplements, any other collagen peptide powder during the study period.
• Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
• If the female subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.

You may not qualify if:

• Subjects must not be enrolled in the study if they meet any one of the following 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).
• Subject has a history of alcohol or drug addiction.
• Subject has plans of shaving scalp hair during the study.
• Subject is currently participating in or planning on starting a weight loss program that may result in a significant change in overall body weight.
• Subject has a history of prior use of skin radiance or wrinkle laser treatment within 3 months.
• Pregnant or breastfeeding or planning to become pregnant during the study period.
• Subject has a history of chronic illness which may influence the cutaneous state.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Collagen Lifesciences Private Limited: collaborator

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, India

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Twenty-Nail Dystrophy; Osteoarthritis, Knee; Acne Vulgaris; Arthralgia

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Nayan K Patel, MBBS

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomly assigned in as 1:1:1:1 ratio to receive either treatment A or B or C or D and three different dosages i.e. 2.5g, 5g, and 10g. The randomization code will be generated by NovoBliss Research. Single-blind will be followed for the evaluators. Subjects will be randomly allocated to one of the treatment groups and one of treatment dose, as per the randomization code. This is single-blind study and blinding will be kept wherein neither the evaluator staff nor the Investigator shall be aware of the test treatment or test treatment dose allocation (except for osteoarthritis patients for Bovine Test Treatment). To maintain blinding, the study staff who involves in treatment dispensing and distribution will not be involved in any other study-related activities.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Medical Director

Model Details: Proof of Science, Randomized, Four-arm, Comparative, Single-Blind, Evaluator-Blinded, Dose Response, Safety and Efficacy Study

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 14, 2022
• Study Start: January 11, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)