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

A Multiple-Dose, Randomized, Double-Blinded, Placebo Controlled Trial To Evaluate The Efficacy Of Hydrolyzed Collagen Peptide In Adult Females

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Manifestations; Wrinkle; Skin
• Intervention / Treatment: Dietary supplement: Hydrolized Collagen Peptide; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey, 27410
    • Recruiting
    • Huseyin Serhat Inaloz
    • Contact: Huseyin S Inaloz, Prof. Dr.; Phone Number: 76506 +903423606060; Email: serhatinaloz@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 are not suitable to any of inclusion criteria.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrolized Collagen Peptide; This arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study.	Dietary supplement: Hydrolized Collagen Peptide; Dietary Hydrolized Collagen Peptide sourced from bovine; Other Names: Collagen
Placebo Comparator: Placebo; This arm will be allocated randomly and receive placebo throughout the study.	Other: Placebo; Placebo look alike the experimental product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on skin roughness	Measurement is based on capturing skin images by using an instrument specifically developed for assign skin health.	3 monhs

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Safety and tolerability of Hydrolized Collagen Peptide	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations
• Other Study ID Numbers: ALP-2021-CL-01-2021/01997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No