Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult Females

NCT05235997 | Unknown

• 1 other identifier: ALP-2021-CL-01-2021/01997
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the contribution of hydrolized collagen products to elasticity, hydration and roughness of the skin of female volunteers. Safety and tolerability of the product is the other objective of this placebo-controlled, randomized study.

Conditions

Skin; Skin Manifestations; Wrinkle

Outcome Measures

Primary Outcomes (2)

• Change on skin elasticity

  Measurement of elasticity based on the stress/deformation method through skin suction by using an instrument specifically developed for assign skin health.

  3 months

• Change on skin hydration

  Measurement is based on the hydration of the stratum corneum through the capacitive method by using an instrument specifically developed for assign skin health.

  3 months

Secondary Outcomes (1)

• Change on skin roughness

  3 monhs

Other Outcomes (1)

• Adverse events

  3 months

Study Arms (2)

Hydrolized Collagen Peptide

EXPERIMENTAL

This arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study.

Dietary Supplement: Hydrolized Collagen Peptide

Placebo

PLACEBO COMPARATOR

This arm will be allocated randomly and receive placebo throughout the study.

Other: Placebo

Interventions

Hydrolized Collagen Peptide DIETARY_SUPPLEMENT

Dietary Hydrolized Collagen Peptide sourced from bovine

Also known as: Collagen

Hydrolized Collagen Peptide

Placebo OTHER

Placebo look alike the experimental product

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female volunteers aged between 35 and 60 years,
• Volunteers who have normal physical examination at screening visit,
• Volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements,
• Volunteers who have normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 100 bpm at least after 5 minutes of rest,
• Volunteers who have understanding of the study and agreement to give a written informed consent.

You may not qualify if:

• Who have atopic constitution or asthma and/or known allergy for biosynthetic collagen products and/or other any of the excipients of the product.
• Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
• Who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study.
• Who have the use of topical retinoids, anti-wrinkle cosmetic products including retinol and/or AHA, or moisture-rich cosmetic products within the 3 months prior to initiation of the study.
• Who use skincare therapy using lasers or peeling within the 3 months prior to initiation of the study.
• Who have current participation in another clinical study, or participation in any type of dermatology study within 3 months.
• Who have any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria.
• Who have the presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
• Who had undergone, or planned to undergo, pregnancy or breastfeeding.
• Who have current intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
• Who are suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgment.
• Who have history of drug abuse.
• Who have relationship to the investigator.
• Who have history of difficulty of swallowing.
• Who are on a special diet due to any reason, or, have gained or lost 5% of baseline weight.

Sponsors & Collaborators

• Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.: lead
• Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.: collaborator

Study Sites (1)

Huseyin Serhat Inaloz

Gaziantep, 27410, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Skin Manifestations

Interventions

Collagen

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 11, 2022
• Study Start: January 31, 2022
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2023
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)