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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235997
• Other study ID #: ALP-2021-CL-01-2021/01997
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: April 2023

Study information

• Verified date: February 2022
• Source: Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin
• Skin Manifestations
• Wrinkle

Intervention

Dietary Supplement:
• Hydrolized Collagen Peptide
Dietary Hydrolized Collagen Peptide sourced from bovine

Other:
• Placebo
Placebo look alike the experimental product

Locations

Country	Name	City	State
Turkey	Huseyin Serhat Inaloz	Gaziantep

Sponsors (2)

Lead Sponsor	Collaborator
Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.	Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Safety and tolerability of Hydrolized Collagen Peptide	3 months
Primary	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
Primary	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	Change on skin roughness	Measurement is based on capturing skin images by using an instrument specifically developed for assign skin health.	3 monhs