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Effect of Recombinant Vegan Collagen in improving aging-related skin parameters in adults

A randomized, comparative, parallel arm, placebo-controlled clinical trial to evaluate the efficacy and safety of Recombinant Vegan Collagen attributing to improving aging-related skin parameters in adults. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063380
Enrollment
120
Registered
2024-02-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Group 2: 0.20g Pepwell GS 70 (contains 0.14g Pepwell): Dissolve the investigational product in 100 mL of water (about half a cup), and consume daily, 30 minutes after dinner for two mon

Sponsors

Jiangsu JLand Biotech Co., Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and females aged 30 to 45 years (both inclusive)2.Participants with any one of the following skin conditions along with mild to moderate wrinkles: • Under-eye dark circles, •Hyperpigmentation spots, • Dry dull skin,3.Participants not on any nutritional supplement or not consuming any therapeutic medication for any disorder for the last 45 days;4.Willingness to complete questionnaires, records, and diaries associated with the study and to complete all visits;5. Provided voluntary, written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Participants with any chronic illness or any clinical condition; 2. Participants who have used a collagen peptide containing supplement in the past 6 months and those who had taken high doses of vitamin C (greater than or equal to 500 mg a day) or any other antioxidant product in the past 1 month; 3. Participants who reported substance abuse (alcohol, tobacco, drugs etc.); 4. Obese individuals (BMI greater than 30 kg per m2); 5. Participation in other clinical trials in last 90 days prior to screening; 6. Females who are pregnant and have a positive urine pregnancy test or planning to be pregnant or lactating or not using reliable methods of contraception; 7. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.

Design outcomes

Primary

MeasureTime frame
1.Assessment of change in wrinkles in the nasolabial and lateral canthal region near the eyes (crow s feet), by using the Modified Fitzpatrick Wrinkle Scale at screening, day 30 and day 60. 2. Assessment of skin hydration and elasticity using Digital Skin Moisture Meter at screening, day 30 and day 60. 3. Assessment of skin firmness using modified Griffiths 10-point scale score at screening, day 30 and day 60. 4. Assessment of changes in wrinkles, blemishes, average pore volume, and porosity index, and roughness by using 3D imaging at screening, day 30 and day 60. [For 12 participants i.e. 3 participants for each group].Timepoint: Screening, Day 30 and Day 60.

Secondary

MeasureTime frame
1.Assessment of changes in skin texture and roughness by Allergan skin roughness scale score at screening, day 30 and 60. 2.Assessment of change in hyperpigmentation and blemishes by using MSIP (melasma severity index; p pigmentation) at screening, day 30 and 60. 3.Assessment of under-eye dark circles for four zones (median and lateral for both eyes) and graded on a bespoke scale at screening, day 30 and 60. 4.Assessment of overall self-esteem by using the Rosenberg Self-Esteem Scale (RSES) at screening and end of the study. 5.Participant Satisfaction Questionnaire: Hydration and moisture to the skin at day 30 and day 60. 6.Dermatological reported radiance of the skin by clinical scoring using the colouring, luminosity, brightness, and transparency (C.L.B.T.) scale and imperfections scale (dark circles, redness, dark spots, and heterogeneity) at screening and day 60.Timepoint: Screening, Day 30 and Day 60.

Countries

India

Contacts

Public ContactDr Gayatri Ganu

Mprex Healthcare Pvt. Ltd.

drgayatri@mprex.in8554912644

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026