NCT07302789

Clinical Effects of Two Oral Bioactive Collagen Peptides On Skin Properties and Aging Hallmarks

Clinical Evaluation of the Improvement of Skin Beauty Parameters After Oral Intake of a Collagen Peptides Supplement in Human Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Bionos Biotech S.L. · Industry
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This randomized, controlled clinical trial evaluated whether daily oral intake of a collagen peptides supplement improved age-associated skin beauty parameters in healthy women with visible facial wrinkles. A total of 68 healthy female volunteers between 35 and 65 years of age (both inclusive) with noticeable facial wrinkles were initially enrolled in this randomized, double-blind, parallel-group clinical study. Participants were allocated in a 1:1 ratio to receive either the active control (n = 34) or avvera™ (n = 34). One participant in the active control group withdrew from the study due to personal reasons and was excluded from the final analysis. Consequently, 67 participants completed the study and were included in the efficacy analyses (active control: n = 33; avvera™: n = 34). Participants consumed one 2,500 mg sachet per day, diluted in water or another beverage, while maintaining their usual diet and skincare routines and avoiding other oral supplements or intensive cosmetic procedures for 8 weeks. The main objectives were to determine whether each collagen supplement, considered independently, (1) improved facial skin elasticity, firmness, and fatigue; (2) reduced wrinkle area, depth, and volume in the crow's-feet region; and (3) enhanced skin hydration and barrier function. At baseline (Day 0) and at weeks 4 and 8, participants attended clinic visits where skin elasticity, firmness, and fatigue were measured with a Cutometer; wrinkles were assessed by VISIA-CR/PRIMOS imaging; skin hydration was measured with a Corneometer; and transepidermal water loss on the cheek was quantified with a Tewameter. The study was designed to assess the efficacy of each product separately, without formal head-to-head comparison between them.

Detailed description

Skin aging is a multifactorial process driven by intrinsic factors (genetic background, hormonal changes, chronological aging) and extrinsic factors such as UV exposure, environment, and lifestyle. Clinically, it is characterized by wrinkles, loss of elasticity and firmness, decreased hydration, and impaired barrier function. Nutraceuticals are increasingly used as complementary strategies to support skin health from within, and hydrolyzed collagen has emerged as a particularly promising ingredient. Collagen peptides derived from bovine hide and processed by enzymatic hydrolysis yield bioactive fragments with good bioavailability and regulatory recognition as safe ingredients for long-term oral intake. However, additional controlled clinical studies were needed to further substantiate their cosmetic benefits on age-related skin parameters. This double-blind, parallel-group cosmetic clinical study was conducted at Bionos Biotech S.L. (Valencia, Spain) to evaluate the effects of daily oral intake of an Italgel S.p.A. Collagen peptides supplement on facial skin beauty parameters in comparison with a commercially available Competitor's supplement. Sixty-eight healthy female volunteers aged 35-65 years with visible wrinkles in the crow's-feet area were enrolled after meeting predefined inclusion and exclusion criteria and signing written informed consent. Participants were allocated in a 1:1 ratio to receive either the active control (n = 34) or avvera™ (n = 34). One participant in the active control group withdrew from the study due to personal reasons and was excluded from the final analysis. Consequently, 67 participants completed the study and were included in the efficacy analyses (active control: n = 33; avvera™: n = 34). Key exclusions included relevant systemic diseases, abnormal liver or kidney function, heavy alcohol intake, current smoking or recent smoking history, use of certain systemic medications (e.g., oral hormones, steroids, obesity drugs, antidepressants), and conditions judged by the investigator as incompatible with participation. Eligible participants were assigned to receive either the Collagen peptides supplement or the Competitor's supplement (30 women per group) for 8 weeks. Both investigational products consisted of pure hydrolyzed bovine collagen supplied in sachets containing 2,500 mg of powder. The collagen was manufactured under European food-safety regulations, using enzymatic hydrolysis to obtain small peptides with high absorption and without added artificial ingredients or E-numbers. Products were labeled as "Product A" and "Product B" so that neither volunteers nor investigators knew which product each participant was taking; the identity code was held by the sponsor. Participants were instructed to dissolve one sachet per day in water or another beverage and to ingest it once daily, preferably in the morning at approximately the same time, for a total of 8 consecutive weeks. Efficacy assessments focused on objective, non-invasive measurements of skin mechanics, wrinkles, hydration, and barrier function. At baseline (Day 0), Week 4, and Week 8, participants attended clinic visits in which facial skin elasticity, firmness, and fatigue were quantified using a Cutometer®; wrinkle area, depth, and volume in the crow's-feet region were analyzed by 3D imaging with VISIA-CR/PRIMOS technology; stratum corneum hydration on the face was measured by Corneometer®; and transepidermal water loss (TEWL) on the cheek was assessed using a Tewameter®. These time points allowed evaluation of changes over time within each treatment group as well as comparison of responses between the Collagen peptides supplement and the Competitor's supplement. Throughout the study, volunteers were asked to maintain their usual eating habits and basic skincare routines and to avoid starting any new oral supplements (including antioxidants or other "beauty from within" products) that could interfere with interpretation of results. Participants were allowed to continue their regular day and night topical care, but they were instructed not to undergo intensive or invasive cosmetic procedures (such as strong peels, aggressive masks, or similar treatments) during the study. Major changes in personal cosmetic routines or lifestyle that might impact study endpoints were discouraged, and contraceptive methods were to remain stable. Compliance with product use and adherence to study instructions were supported through written guidelines and close contact with the research team. Safety was monitored throughout the 8-week intervention. Hydrolyzed collagen is widely used in supplements and is generally regarded as safe, and no health risks were anticipated at the doses used. Nevertheless, volunteers were instructed to seek medical attention immediately if they experienced any adverse events, and the attending healthcare professionals could recommend temporary or permanent discontinuation of the product if needed. All adverse events and any serious undesirable events were to be documented and reported to the sponsor and ethics committees according to regulatory timelines, and participants who discontinued were followed until resolution of any study-related effects. For the analysis, results obtained before and after supplementation were used to determine the effects of oral collagen intake on the different skin parameters. Data were analyzed statistically using an unpaired Student's t-test with a two-sided significance level of 0.05 (95% confidence interval). Based on prior experience of Bionos Biotech S.L. in similar clinical studies, a total sample size of 67 women was considered sufficient to detect differences on the order of approximately 5-10% with 80% power, while acknowledging that exact effect sizes could not be predicted in advance. The study was primarily designed to characterize the efficacy profile of each collagen supplement; any comparative interpretation between products was to be made by the sponsor. The trial was conducted in accordance with the Declaration of Helsinki, ICH guidelines, and applicable national regulations. The protocol, informed consent document, and study materials were reviewed and approved by the relevant Ethics Committee in Clinical Research and the regional health authority of the Generalitat Valenciana before initiation. All participants provided written informed consent prior to any study procedures. Study data were recorded in source documents and case report forms and then coded to protect participant identity in line with Spanish data protection legislation; the sponsor had access only to anonymized study data. Essential documents, signed consent forms, and accountability records for the investigational products were retained by the investigator in accordance with regulatory requirements and the sponsor's policies.

Conditions

• Skin Ageing
• Facial Wrinkles - Rough Texture - Hyperpigmentation
• Skin Hydration in Healthy Volunteers

Interventions

Type	Name	Description
OTHER	Dietary Supplement: Collagen Peptides Supplement	Participants will be provided with the Collagen peptides supplement and instructed to take one sachet orally once daily for 8 weeks (one 2,500 mg sachet diluted in water or another beverage, preferably in the morning at approximately the same time each day). Efficacy will be evaluated at baseline and at approximately 4 and 8 weeks after the first intake by measuring facial skin elasticity, firmness, and fatigue with a Cutometer®, wrinkle area/depth/volume in the crow's-feet region with VISIA-CR®/PRIMOS® 3D imaging, skin hydration with a Corneometer®, and skin barrier function (transepidermal water loss) on the cheek with a Tewameter®. The product is a pure hydrolyzed bovine collagen peptides powder (2,500 mg per sachet), free of artificial additives/E-numbers and compliant with EU food regulations. All procedures and instrumental measurements take place at Bionos Biotech S.L. facilities.
OTHER	Dietary Supplement: Competitor's Collagen Supplement	Participants will be provided with the Competitor's collagen supplement and instructed to take one sachet orally once daily for 8 weeks (one 2,500 mg sachet diluted in water or another beverage, preferably in the morning at approximately the same time each day). Efficacy will be evaluated at baseline and at approximately 4 and 8 weeks after the first intake using the same non-invasive methods: Cutometer® (elasticity, firmness, fatigue), VISIA-CR®/PRIMOS® 3D imaging (crow's-feet wrinkle area, depth, and volume), Corneometer® (facial skin hydration), and Tewameter® (transepidermal water loss on the cheek). The product is a pure hydrolyzed bovine collagen peptides powder (2,500 mg per sachet), currently marketed as a collagen supplement and compliant with international food-safety regulations. All procedures and instrumental measurements take place at Bionos Biotech S.L. facilities.

Timeline

• Start date: 2025-02-26
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2025-12-24
• Last updated: 2026-02-17

Locations

1 site across 1 country: Spain