Skin, Skin Manifestations, Wrinkle
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHydrolized Collagen Peptide
Dietary Hydrolized Collagen Peptide sourced from bovine
OTHERPlacebo
Placebo look alike the experimental product
Sponsors
Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on skin elasticity | 3 months | 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 | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change on skin roughness | 3 monhs | Measurement is based on capturing skin images by using an instrument specifically developed for assign skin health. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 3 months | Safety and tolerability of Hydrolized Collagen Peptide |
Countries
Turkey (Türkiye)
Outcome results
None listed