SkinNCT05235997
Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult Females
A study testing Hydrolized Collagen Peptide in people with Skin and Skin Manifestations, run by Sel Sanayi Urunleri Ticaret ve Pazarlama A.S. at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin, Skin Manifestations, Wrinkle
- What is being tested?
- Hydrolized Collagen Peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Huseyin Serhat Inaloz
Gaziantep, 27410
Huseyin S Inaloz, Prof. Dr., +903423606060 ext. 76506, serhatinaloz@hotmail.com
About this study
Official title: A Multiple-Dose, Randomized, Double-Blinded, Placebo Controlled Trial To Evaluate The Efficacy Of Hydrolyzed Collagen Peptide In Adult Females
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
- Being tested
- Hydrolized Collagen Peptide, Placebo
- Medical subject headings
- Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolized Collagen PeptideDietary supplement
Also called Collagen
Dietary Hydrolized Collagen Peptide sourced from bovine
PlaceboOther
Placebo look alike the experimental product
| Study group | Role | What they receive |
|---|---|---|
| Hydrolized Collagen Peptide | Experimental | This arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study. Receives: Dietary Supplement: Hydrolized Collagen Peptide |
| Placebo | Placebo comparator | This arm will be allocated randomly and receive placebo throughout the study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (1)
Change on skin roughness
Measurement is based on capturing skin images by using an instrument specifically developed for assign skin health.
Measured: 3 monhs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start31 Jan 2022
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235997
- Sponsor's protocol ID
- ALP-2021-CL-01-2021/01997
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Randomized, Double-Blinded, Placebo Controlled Trial To Evaluate The Efficacy Of Hydrolyzed Collagen Peptide In Adult Females
- ClinicalTrials.gov ID
- NCT05235997
- Acronym / sponsor ID
- ALP-2021-CL-01-2021/01997
- Conditions
- Skin, Skin Manifestations, Wrinkle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.Industry (pharma, biotech, devices)
- Collaborators
- Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolized Collagen Peptide | Experimental | Dietary Supplement: Hydrolized Collagen PeptideThis arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study. |
| Placebo | Placebo comparator | Other: PlaceboThis arm will be allocated randomly and receive placebo throughout the study. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolized Collagen PeptideAlso: CollagenDietary Hydrolized Collagen Peptide sourced from bovine | Dietary supplement | Hydrolized Collagen Peptide |
| PlaceboPlacebo look alike the experimental product | Other | Placebo |
Primary outcome
Change on skin elasticity
Time frame: 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
Time frame: 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.
1 secondary outcome
Change on skin roughness
Time frame: 3 monhs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolized Collagen Peptide in people with Skin and Skin Manifestations, run by Sel Sanayi Urunleri Ticaret ve Pazarlama A.S. at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on skin elasticity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.