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

NCT07302789 | Completed

• 1 other identifier: Collagen peptides suppl_2025
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Collagen peptides; Oral collagen supplement; Skin aging; Facial wrinkles; Skin elasticity; Skin firmness; Skin hydration; Transepidermal water loss (TEWL)

Outcome Measures

Primary Outcomes (4)

• Quantification of the change in facial wrinkle parameters (area, length, depth, and volume) in the crow's-feet region from baseline to post-treatment visits using 3D imaging.

  Sixty healthy women (35-65 years) with visible wrinkles in the crow's-feet area will take either a Collagen peptides supplement or a Competitor's collagen supplement once daily for 8 weeks. Facial wrinkles, with emphasis on crow's feet, will be assessed using the Visia-CRP-5 Primos system (Canfield Scientific, USA). Standardized images (clean skin, closed eyes, neutral expression) will be captured at three angles (left 45°, frontal, right 45°) using a stabilization rig. 3D reconstructions will be analyzed to quantify wrinkle area, length, depth, and volume in predefined regions of interest. Changes in these parameters from baseline to post-treatment visits will be calculated within each treatment group. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; products are supplied in individual single-dose sachets and stored according to the manufacturer's instructions.

  Baseline (Day 0) and at approximately Day 28 (~4 weeks) and Day 56 (~8 weeks) of treatment.

• Quantification of the change in facial skin firmness, elasticity, and fatigue from baseline to post-treatment visits using Cutometer®.

  Sixty healthy women (35-65 years) with visible wrinkles in the crow's-feet area will take either a Collagen peptides supplement or a Competitor's collagen supplement 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). Facial skin mechanical properties will be quantified using a Cutometer® MPA 580 (Courage + Khazaka, Cologne, Germany), which applies controlled negative pressure to the skin and optically records vertical displacement. Firmness (R0), elasticity (R5), and skin fatigue/viscoelastic "tiring" (R3) will be derived from the deformation-recovery curve. Measurements will be taken on the cheek of each volunteer at every study time point, with multiple (e.g., five) replicate readings per site, averaged to obtain a single value per subject and visit. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; products are supplied in individual single-dose sa

  Baseline (Day 0, before product intake) and at approximately Day 28 (~4 weeks) and Day 56 (~8 weeks) of treatment

• Quantification of the change in facial skin hydration and transepidermal water loss (TEWL) from baseline to post-treatment visits using Corneometer® and Tewameter®.

  Sixty healthy women (35-65 years) with visible wrinkles in the crow's-feet area will take either a Collagen peptides supplement or a Competitor's collagen supplement once daily for 8 weeks. Skin hydration will be quantified with a Corneometer® CM 825 (Courage + Khazaka, Cologne, Germany), which measures changes in capacitance related to epidermal water content in the upper stratum corneum. TEWL will be assessed with a Tewameter® TM 300, based on an open-chamber method that calculates the water vapor gradient above the skin surface. Both parameters will be measured on the cheek of each volunteer at every study time point, with several replicate readings per subject and visit averaged to obtain a single value. Results will be expressed as absolute values and as percent change from baseline. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; products are supplied in individual single-dose sachets and stored according to the manufacturer's instructions.

  Baseline (Day 0) and at approximately Day 28 (~4 weeks) and Day 56 (~8 weeks) of treatment.

• Completion of a structured self-assessment questionnaire on perceived efficacy and skin appearance

  Sixty healthy women (35-65 years) with visible wrinkles in the crow's-feet area will take either a Collagen peptides supplement or a Competitor's collagen supplement once daily for 8 weeks. Perceived efficacy will be evaluated using a structured self-assessment questionnaire completed by each participant after 56 days of treatment. Responses will be recorded on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree), with satisfaction for positive items defined as scores ≥4. For selected items, participants will provide binary yes/no answers. The questionnaire will capture subjective perceptions of changes in skin hydration, smoothness, firmness, wrinkle appearance, and overall skin quality. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; products are supplied in individual single-dose sachets and stored according to the manufacturer's instructions.

  Approximately Day 56 (~8 weeks) of treatment.

Study Arms (2)

Collagen Peptides Supplement

EXPERIMENTAL

34 healthy women aged 35-65 years with visible wrinkles in the crow's-feet area receive a daily oral collagen peptides supplement for 8 weeks. Participants take one sachet per day while maintaining their usual diet and skincare routines and avoiding new oral supplements or intensive cosmetic procedures.

Other: Dietary Supplement: Collagen Peptides Supplement

Competitor's Collagen Supplement

ACTIVE COMPARATOR

33 healthy women aged 35-65 years with visible wrinkles in the crow's-feet area receive a daily oral competitor collagen supplement for 8 weeks. Participants take one sachet per day while maintaining their usual diet and skincare routines and avoiding new oral supplements or intensive cosmetic procedures.

Other: Dietary Supplement: Competitor's Collagen Supplement

Interventions

Dietary Supplement: Competitor's Collagen Supplement OTHER

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.

Competitor's Collagen Supplement

Dietary Supplement: Collagen Peptides Supplement OTHER

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.

Collagen Peptides Supplement

Eligibility Criteria

• Age: 35 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female volunteers.
• Between 35-65 years old (both included).
• With noticeable wrinkles (wrinkles in the crow's feet area).
• Subjects with absence of any infectious disease within the 4 weeks previous to the study.
• Informed of the purpose and the protocol of the study and signed a written informed-consent form.

You may not qualify if:

• Diagnosis of any diseases such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease.
• Consume more than the recommended alcohol guidelines i.e. \>14 units/week for females (europa.eu).
• Current smoking habit or history of smoking within the past 1 year.
• History of depression, schizophrenia, alcoholism, drug addiction, or mental illness.
• Current or previous intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
• History of asthma or autoimmune disease Use of oral hormone therapies ie. cortisone or steroids in the 6 months prior to initiation of the study.
• Abnormal liver function or abnormal renal function.
• Blood pressure \>140/90 mmHg or hypertension with intake of a diuretic.
• Any condition judged by the investigator to be unsuitable for participation in the study.

Sponsors & Collaborators

• Bionos Biotech S.L.: lead

Study Sites (1)

Bionos Biotech S.L., LabAnalysis Life Science

Valencia, 46007, Spain

Location

Study Officials

• Adela Serrano Gimeno, PhD

  Bionos Biotech S.L. , LabAnalysis Life Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was conducted as a double-blind, parallel-group cosmetic trial. The investigational collagen peptides supplement and the comparator collagen supplement were packaged and labeled as "Product A" and "Product B," so that participants, care providers, investigators, and outcomes assessors were all unaware of group assignment. The treatment code was held by the sponsor/designee and was not broken until completion of data collection and database lock, except in case of a medical emergency requiring individual unblinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: February 26, 2025
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)