Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult Females
Primary Purpose
Skin, Skin Manifestations, Wrinkle
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hydrolized Collagen Peptide
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Skin
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.
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.
Sites / Locations
- Huseyin Serhat InalozRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrolized Collagen Peptide
Placebo
Arm Description
This arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study.
This arm will be allocated randomly and receive placebo throughout the study.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change on skin roughness
Measurement is based on capturing skin images by using an instrument specifically developed for assign skin health.
Full Information
NCT ID
NCT05235997
First Posted
January 7, 2022
Last Updated
February 9, 2022
Sponsor
Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
Collaborators
Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
1. Study Identification
Unique Protocol Identification Number
NCT05235997
Brief Title
Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult Females
Official Title
A Multiple-Dose, Randomized, Double-Blinded, Placebo Controlled Trial To Evaluate The Efficacy Of Hydrolyzed Collagen Peptide In Adult Females
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
Collaborators
Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin, Skin Manifestations, Wrinkle
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrolized Collagen Peptide
Arm Type
Experimental
Arm Description
This arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm will be allocated randomly and receive placebo throughout the study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrolized Collagen Peptide
Other Intervention Name(s)
Collagen
Intervention Description
Dietary Hydrolized Collagen Peptide sourced from bovine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo look alike the experimental product
Primary Outcome Measure Information:
Title
Change on skin elasticity
Description
Measurement of elasticity based on the stress/deformation method through skin suction by using an instrument specifically developed for assign skin health.
Time Frame
3 months
Title
Change on skin hydration
Description
Measurement is based on the hydration of the stratum corneum through the capacitive method by using an instrument specifically developed for assign skin health.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change on skin roughness
Description
Measurement is based on capturing skin images by using an instrument specifically developed for assign skin health.
Time Frame
3 monhs
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Safety and tolerability of Hydrolized Collagen Peptide
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Facility Information:
Facility Name
Huseyin Serhat Inaloz
City
Gaziantep
ZIP/Postal Code
27410
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huseyin S Inaloz, Prof. Dr.
Phone
+903423606060
Ext
76506
Email
serhatinaloz@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult Females
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