None listed
Conditions
Interventions
Intervention1: Test Product 1: Powder beverage containing recombinant collagen [Derived through microbial fermentation using a genetically modified strain of Komagataella phaffii (Pichia pastoris)]: 1
Sponsors
Jiangsu Trautec Medical Technology Co., Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult males and/or non-pregnant, non-lactating female participants (preferably equal distribution) aged 30 to 45 years (both inclusive at the time of consent). 2. Participants with facial wrinkles graded 1 to 2 on the Modified Fitzpatrick Wrinkle Scale. 3. Participants with under-eye dark circles graded 2 or 3 on the 6-point grading scale. 4. Participants with photo type IV and below. 5. Participants with at least 2 pigmentary spots (blemishes/dark spots) present on their face. 6. Participants with brittle nails. 7. Participants are in good general health as assessed by the Investigator based on medical history, vital signs, and laboratory evaluations [CBC (Hemoglobin, RBC, Total WBC, Differential WBC, Hematocrit and Platelets), LFT (SGOT, SGPT, total bilirubin, total protein, albumin), RFT (BUN, creatinine), Lipid parameters (total cholesterol, triglyceride) and glucose]. 8. Female participants of childbearing potential must have a negative urine pregnancy test performed at enrollment visit. 9. Participants who are willing to use acceptable forms of contraception, as applicable. 10. Participants who are not currently undergoing any dermatological treatment or prescribed medication for pigmentation or skin lightening. 11. Participants who are willing to consume the provided study product as instructed during the study period. 12. Participants with the following dietary habits: non-vegetarians, vegetarians who consent to participate, or individuals who occasionally consume non-vegetarian food. 13. Participants who are willing to provide blood samples as per study requirement. 14. Participants who agree to avoid direct sun exposure during the study and adopt protective measures (e.g., carrying an umbrella) when outdoors. 15. Participants who are willing to participate in the study and provide signed informed consent. 16. Participants who are literate and able to complete the diary sheet. 17. Participants who are willing and able to comply with all study procedures and protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Participants with known allergies to fish gelatin, soya, milk or milk products, egg, gluten, wheat flour, or related food items. 2. Participants with a history of hypersensitivity or allergic reactions to medications. 3. Participants who are planning pregnancy during the study period. 4. Participants with active dermatological condition (e.g., psoriasis, atopic dermatitis, rosacea etc.), that may interfere with clinical assessments. 5. Participants with excessive hair, moles, open wounds, cuts, abrasions, irritation, tattoos, scars, sunburn or any dermatological condition on the test site(s) that could affect evaluations. 6. Participants with chronic illness which may influence the cutaneous state. 7. Participants with drug-induced acne as disclosed by participants. 8. Participants with any pigmentary disorder, including freckles and melasma. 9. Participants with uncontrolled hypertension or diabetes mellitus (except those on antihypertensive medications without NO synthesis mechanism). 10. Participants with clinically significant medical conditions requiring treatment (e.g., cardiovascular, dyslipidemia, endocrine, digestive, urinary, neuropsychiatric disorders, or malignant tumors). [Participation allowed if no recurrence for more than 5 years post-surgery). 11. Participants who are likely to undergo surgery during the study period. 12. Participants who have used oral or topical steroids, retinoids or antihistamines within 24 weeks prior to screening. 13. Participants who have used medications or herbal products that may affect study results within 12 weeks prior to screening [e.g., hormones, oral contraceptives, diuretics, acne or hair loss medications, allergic rhinitis medications, ACE inhibitors among hypertension medicines, etc.]. 14. Participants who have continuously consumed dietary supplements or functional foods that could affect study results within 12 weeks prior to screening (e.g., Dietary supplements or conventional foods containing ingredients similar to the study product, protein-containing food, collagen-containing product, hyaluronic acid, biotin, brewer yeast, skin lactic acid bacteria, aloe gel, konjac potato, pomegranate-containing products, Vitamin C, ceramide, gamma-linolenic acid, sheep placenta, N-acetyl glucosamine, noni fruit, chlorella, spirulina, etc.). 15. Participants who have used cosmetics or medicines with similar ingredients on test areas within 12 weeks prior to screening. 16. Participants who underwent dermatological procedures (e.g., dermabrasion, Botox, laser, skin lightening treatments, other skin treatments, etc.) on the study areas within 24 weeks prior to screening. 17. Participants who have started, stopped, or changed his/her hormonal treatment (including contraceptive pill for females) within 1 month prior to the study. 18. Participants with chronic gastrointestinal issues (e.g., frequent indigestion, acidity, gas, bloating or GERD). 19. Participants who are unwilling to avoid unprotected sun or UV exposure during the study. 20. Participants with history of drug and/or alcohol abuse. 21. Participants who have participated in similar clinical trials/studies within 24 weeks prior to screening. 22. Participants with any other condition which could warrant exclusion from the study, as per the Dermatologist s/investigator s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermatological assessment of wrinkles of the nasolabial region and lateral canthal area (crows feet) using the Modified Fitzpatrick Wrinkle Scale. Dermatological assessment of the visibility of under eyes dark circles (sallowness) using 6-point grading scale. Instrumental assessment of fine lines or wrinkles of crows feet area using 3D analysis system Antera.Timepoint: Day 00, Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatological assessment of skin roughness using Allergan skin roughness scaleTimepoint: Day 00, Day 30 and Day 60;Dermatological assessment of the visibility of pigmentary spots using 9-point scaleTimepoint: Day 00, Day 30 and Day 60;Dermatological assessment of hair texture, oiliness, shine, dryness and volume using grading scaleTimepoint: Day 00, Day 30 and Day 60;Dermatological assessment of nail brittleness using Global improvement ratingTimepoint: Day 00, Day 30 and Day 60;Instrumental assessment of skin hydration using Corneometer CM 825.Timepoint: Day 00, Day 30 and Day 60;Instrumental assessment of skin elasticity and firmness using Cutometer Dual MPA 580Timepoint: Day 00, Day 30 and Day 60;Instrumental assessment of skin gloss using Skin-Glossymeter GL 200Timepoint: Day 00, Day 30 and Day 60;Instrumental assessment of pigmentation, pores and skin texture using 3D analysis system AnteraTimepoint: Day 00, Day 30 and Day 60;Instrumental assessment of skin thickness using UltrasonographyTimepoint: Day 00 and Day 60;Assessment of overall self-esteem of participant using standard questionnaireTimepoint: Day 00 and Day 60;Participant Satisfaction QuestionnaireTimepoint: Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactDr Parth Joshi
Cliantha Research
Outcome results
None listed