Clinical trial NCT05235997: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Skin
Skin Manifestations
Wrinkle
Lead sponsor: Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
Sponsor class: INDUSTRY
Collaborators: name: Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
First posted: 2022-02-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change on skin elasticity
timeFrame: 3 months
measure: Change on skin hydration
timeFrame: 3 months
Secondary outcomes:
measure: Change on skin roughness
timeFrame: 3 monhs
Other outcomes:
measure: Adverse events
timeFrame: 3 months
Locations:
city: Gaziantep
country: Turkey
facility: Huseyin Serhat Inaloz
Study officials:
References: