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

NCT ID: NCT05235997

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Hydrolized Collagen Peptide

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

Group Type: EXPERIMENTAL

Hydrolized Collagen Peptide

Intervention Type: DIETARY_SUPPLEMENT

Dietary Hydrolized Collagen Peptide sourced from bovine

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo look alike the experimental product

Interventions

Hydrolized Collagen Peptide

Dietary Hydrolized Collagen Peptide sourced from bovine

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo look alike the experimental product

Intervention Type: OTHER

Other Intervention Names

Collagen

Eligibility Criteria

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.

• 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.

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.

UNKNOWN

Sponsor Role: collaborator

Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huseyin Serhat Inaloz

Gaziantep, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Huseyin S Inaloz, Prof. Dr.

Role: primary

serhatinaloz@hotmail.com

+903423606060 ext. 76506

Other Identifiers

ALP-2021-CL-01-2021/01997

Identifier Type: -

Identifier Source: org_study_id