Mild to Moderate AcneNCT05613660
A Proof of Science, Dose-Response Study to Evaluate the Safety, Efficacy of Different Dosages of Test Treatments
A study testing Veg Collagen Peptide, Bovine Collagen Peptide and Fish | Marine Collagen Peptide in people with Mild to Moderate Acne and Stiffness of Joint, Nec, Involving Ankle and Foot in MDR24_1, run by NovoBliss Research Pvt Ltd at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Mild to Moderate Acne, Stiffness of Joint, Nec, Involving Ankle and Foot in MDR24_1, Other Specified Diseases of Hair and Hair Follicles
- What is being tested?
- Veg Collagen Peptide, Bovine Collagen Peptide and Fish | Marine Collagen Peptide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteIndia
- Study dates
- 11 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject must fulfil all of the following inclusion criteria to be eligible for participation in the study unless otherwise specified.
- 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.
Show all 22Show fewer
- 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.
- If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- Subject is willing not to introduce any new soaps, cleansers, lotions, creams, or any other face product etc. for the duration of the study.
- Subject is willing to give written informed consent and are willing to follow the study procedure.
- Subject is committed not to not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study.
- The subject is willing to use test treatment throughout the study period.
- Only For Bovine Arm: Subjects with osteoarthritis patients having present complaints of pain and stiffness in joints (based on their current prescription and medical history).
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- 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.
- Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or skin care products within the last four weeks
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- 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
- Being tested
- Veg Collagen Peptide, Bovine Collagen Peptide, Fish | Marine Collagen Peptide, Chicken Collagen Peptide
- Keywords
- Acne, Wrinkles, Joints pain, brittle nails, hair fall
- Medical subject headings
- Enterocolitis, Necrotizing, Twenty-Nail Dystrophy, Osteoarthritis, Knee, Acne Vulgaris, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veg Collagen PeptideDietary supplement
Also called VEGCOL™️
Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water
Bovine Collagen PeptideDietary supplement
Also called PROCOL
Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water
Fish | Marine Collagen PeptideDietary supplement
Also called AQUACOL
Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water
Chicken Collagen PeptideDietary supplement
Also called CALCOL
Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Chicken Collagen Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
To evaluate the effectiveness of the test treatments for change in Physician Global Assessment (PGA) scoring using the Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness after 8 weeks of treatment, between treatments, between three different dosages and within the treatment evaluated by dermatologist trained scorer
Measured: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Change in Glogau Skin Age
To evaluate the effectiveness of the test treatments for change in Glogau Skin Age after 8 weeks of treatment, between treatments, between three different dosages and within the treatment evaluated by a dermatologist trained scorer
Measured: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Change on hair strength by Pull test
To evaluate the effectiveness of the test treatments for change in scalp hair strength using the pull test method evaluated by dermatologist-trained scorer after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment
Measured: 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
To evaluate the effectiveness of the test treatments for change in Physician Global Assessment (PGA) score for assessment of the signs of brittle nails, surface roughness, raggedness, and peeling evaluated by dermatologist-trained scorer after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment
Measured: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Change in Sleep Quality using Leeds Sleep Evaluation Questionnaires (LSEQ)
To evaluate the effectiveness of the test treatments for change in Sleep Quality using Leeds Sleep Evaluation Questionnaires (LSEQ) evaluated by trained staff after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment
Measured: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Consumption of Rescue Medications for Joints pain
To evaluate the effectiveness of the test treatments for the requirement of consumption of rescue medications for Joints pain during and after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment
Measured: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Test treatment perception and consumer feedback on Skin elasticity, suppleness, deep and sound sleep, digestion and gut health, joint health, and nail and hair health
To evaluate the effectiveness of the test treatments perception and consumer feedback on skin elasticity, suppleness, deep and sound sleep, digestion and gut health, joint health, and nail and hair health using hedonic questionnaires evaluated by trained study staff after 8 weeks of treatment, between treatments, between three different dosages, and within the treatment
Measured: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Change in Physician Global Assessment (PGA) score for assessment of Acne Severity
To evaluate the effectiveness of the test treatments for change in PGA score of acne severity evaluated by dermatologist trained scorer in enrolled subjects with mild to moderate acne - between treatments, between three different dosages, and within the treatment
Measured: Baseline (Day01) to Day 60 (+2Days)
Change in Anagen Telogen (A:T) ratio
To evaluate the effectiveness of the test treatments after 8 weeks of treatment in Anagen Telogen (A:T) ratio using pluck test - between treatments, between three different dosages and within treatment evaluated by dermatologist trained scorer to assess Hair growth cycle (Trichogram)
Measured: Baseline (Day01) to Day 60 (+2Days)
Change in facial photographs (left/center/right) and nails photographs of the subjects
Change in facial photographs (left/center/right) and nails photographs of the subjects in three different dosages and between treatments will be presented at the end of the study
Measured: Baseline (Day01) to Day 60 (+2Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start11 Jan 2023
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Proof of Science, Randomized, Four-arm, Comparative, Single-Blind, Evaluator-Blinded, Dose Response, Safety and Efficacy Study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Collagen Lifesciences Private Limited
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr Nayan K Patel, MBBS, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613660
- Sponsor's protocol ID
- NB220031-COL
- Status last verified
- Dec 2023
- First submitted
- 30 Oct 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05613660
- Acronym / sponsor ID
- NB220031-COL
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Collagen Lifesciences Private Limited
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Proof of Science, Randomized, Four-arm, Comparative, Single-Blind, Evaluator-Blinded, Dose Response, Safety and Efficacy Study
| Arm | Type | Receives |
|---|---|---|
| VEGCOL™️ (Veg Collagen Peptide) | Experimental | Dietary Supplement: Veg Collagen PeptideMode 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. |
| PROCOL (Bovine Collagen Peptide) | Experimental | Dietary Supplement: Bovine Collagen PeptideBovine 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. |
| AQUACOL (Fish | Marine Collagen Peptide) | Experimental | Dietary Supplement: Fish | Marine Collagen PeptideMarine 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. |
| CALCOL (Chicken Collagen Peptide) | Experimental | Dietary Supplement: Chicken Collagen PeptideChicken 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- The subject must fulfil all of the following inclusion criteria to be eligible for participation in the study unless otherwise specified.
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veg Collagen PeptideAlso: VEGCOL™️Mode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water | Dietary supplement | VEGCOL™️ (Veg Collagen Peptide) |
| Bovine Collagen PeptideAlso: PROCOLMode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water | Dietary supplement | PROCOL (Bovine Collagen Peptide) |
| Fish | Marine Collagen PeptideAlso: AQUACOLMode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water | Dietary supplement | AQUACOL (Fish | Marine Collagen Peptide) |
| Chicken Collagen PeptideAlso: CALCOLMode of Usage: 1 scoop/sachet daily Route of Administration: Oral administration with a glassful (approx. 250 mL) of water | Dietary supplement | CALCOL (Chicken Collagen Peptide) |
Primary outcome
Change in the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
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
Change in Skin Elasticity
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
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
Change in Skin Hydration
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
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
Change in Hair Thickness and Density
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
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
Change in Hair Fall
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
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
Change in Body Weight and BMI
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
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
Change in Joints Pain using VAS (0-10 cm) scoring evaluated by trained study staff
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
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
Change in muscles strength
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
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
To assess the effect of test treatment in terms of change in hair growth on the scalp
Time frame: 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)
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
10 secondary outcomes
Change in Physician Global Assessment (PGA) scoring - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Change in Glogau Skin Age
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Change on hair strength by Pull test
Time frame: 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
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Change in Sleep Quality using Leeds Sleep Evaluation Questionnaires (LSEQ)
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Consumption of Rescue Medications for Joints pain
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Test treatment perception and consumer feedback on Skin elasticity, suppleness, deep and sound sleep, digestion and gut health, joint health, and nail and hair health
Time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)
Change in Physician Global Assessment (PGA) score for assessment of Acne Severity
Time frame: Baseline (Day01) to Day 60 (+2Days)
Change in Anagen Telogen (A:T) ratio
Time frame: Baseline (Day01) to Day 60 (+2Days)
Change in facial photographs (left/center/right) and nails photographs of the subjects
Time frame: Baseline (Day01) to Day 60 (+2Days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Mild to Moderate Acne
Recruiting
Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris
Acne Vulgaris
Recruiting
Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris
Acne Vulgaris
Recruiting
Safety and Efficacy of Skincare Products for Managing Mild to Moderate Acne in Individuals With Sensitive Skin
Acne
Not yet recruitingPhase 1/2
Comparative Effectiveness of Clindamycin-Retinoid, Clindamycin-Retinoid-Dexamethasone, and 10% SM-hUCMSC Secretome Gel in the Improvement of Mild-to-Moderate Acne Vulgaris
Acne Vulgaris
Not yet recruitingObservational study
Non-interventional Translational Study in Mild, Moderate and Severe Acne Patients
Acne
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Nayan K Patel, MBBS principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veg Collagen Peptide, Bovine Collagen Peptide and Fish | Marine Collagen Peptide in people with Mild to Moderate Acne and Stiffness of Joint, Nec, Involving Ankle and Foot in MDR24_1, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the facial wrinkles and fine lines of Crow's feet area, skin texture - roughness, dryness, wrinkles, smoothness (time frame: Baseline (Day01) to Day 10 (+2Days), Day 30 (+2Days) and Day 60 (+2Days)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.