Chronological Aging of SkinPhase 1/2NCT02303496
Autologous Platelet-Rich Plasma Cream for Photoaging and Chronological Skin Aging
A Phase 1/2 study testing Platelet Rich Plasma Cream in people with Chronological Aging of Skin and Photoaging of Skin, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
Human skin undergoes some morphological changes with the effects of chronological aging and photoaging, these are especially remarkable in the facial skin. Changes in pigmentation, sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and chronologic aging of skin. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronological Aging of Skin, Photoaging of Skin
- What is being tested?
- Platelet Rich Plasma Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Dec 2014to May 2015
- Phase
- Phase 1/2
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient has periorbital wrinkles with Glogau Scale 3 or more
Who cannot join
- Patients with precancerous lesions
- Patients with inflammatory skin disease like rosacea, psoriasis, seborrheic eczema
- Patients with connective tissue disease like lupus erythematosus
- Patients have a cosmetic intervention to their face, like chemical peel, infrared, radio frequency, laser, fillers or botulinum toxin injections in last 6 months
- Patients who use an anti aging cream containing retinoic acid, vitamin C and peptides in last 3 months
- Pregnant or lactating females
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acibadem Labcell
Istanbul, Fahrettin Kerim Gokay Saint No:49, 34662
Ercument Ovali, Prof.Dr., +905325729174, ercument.ovali@acibademlabcell.com.tr
Fatma Eyuboglu Unuvar, Msc., +905413091649, fteyuboglu@gmail.com
Acibadem Kozyatagi Hospital
Istanbul, Inonu Saint No.20 Kozyatagi, 34742
Ozgur Bakar, Ass. Prof., ++905323170351, ozgurtimurkaynak@hotmail.com
About this study
Official title: The Effects of Autologous Platelet-Rich Plasma Cream on Photoaging and Chronological Skin Aging
Human skin undergoes some morphological changes with the effects of chronological aging and photoaging, these are especially remarkable in the facial skin. Changes in pigmentation, sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and chronologic aging of skin. With the increasing demand, it needs to provide new approach for the prevention and treatment of these morphological changes.
Fibroblasts have a key role on skin aging. It is known that platelet rich plasma activates the fibroblasts and increases the synthesis of collagen and other type of matrix components. Because of these specialities, platelet rich plasma is thought to be effective on skin aging.
Read the detailed description
Clinical evaluation of the patients will be done for five times during 3 months. 0th day (Basal), 7th day, 15th day, 45th day and 105th day.
- Conditions
- Chronological Aging of Skin, Photoaging of Skin
- Being tested
- Platelet Rich Plasma Cream, Placebo - Sterile Water Cream
- Keywords
- platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma CreamBiological
Cream Containing Platelet Rich Plasma and Oleaginous Base
Placebo - Sterile Water CreamBiological
Cream Containing Sterile Water and Oleaginous Base
| Study group | Role | What they receive |
|---|---|---|
| PRP Cream Application | Experimental | Application of Cream Containing Platelet Rich Plasma and Oleaginous Base Receives: Biological: Platelet Rich Plasma Cream |
| SW Cream Application - Placebo | Active comparator | Application of Cream Containing Sterile Water and Oleaginous Base Receives: Biological: Placebo - Sterile Water Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global efficacy evaluations and quantitative analyzes.
Evaluation of deep and fine wrinkling, amount of pigmentation, amount of vascularization, clarity of skin assessment done by the patient and the investigator. Quantitative analyzes: Measurements of Antera and Cutometer.
Measured: T4 (105th day)
Secondary outcomes (7)
Deep and fine wrinkling,
It will be scored from 0 to 10, by patients and the investigator
Measured: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Number of Participants with Adverse Events and Type of Adverse Effects.
Clinical evaluation of erythema, edema, xerosis, scaling. Each item will be scored from 0 to 3 by investigator
Measured: T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Smell and texture of cream
Patient satisfaction about smell and texture of cream. Each item will be scored from 0 to 3. (0: Very Bad, 1: Bad, 2: Good, 3: Very good)
Measured: T4 (105th day)
Changes from baseline and placebo group.
The percentage of change of the evaluated parameters (listed as 1-4), from baseline (T0 vs T1,T2,T3,T4) and differences from the placebo group.
Measured: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Amount of pigmentation
It will be scored from 0 to 10, by patients and the investigator
Measured: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Amount of vascularization
It will be scored from 0 to 10, by patients and the investigator
Measured: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Clarity of skin
It will be scored from 0 to 10, by patients and the investigator
Measured: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronological Aging of SkinStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercument Ovali, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303496
- Sponsor's protocol ID
- PRP-CREAM-1
- Status last verified
- Nov 2014
- First submitted
- 14 Nov 2014
- Last updated
- 1 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Autologous Platelet-Rich Plasma Cream on Photoaging and Chronological Skin Aging
- ClinicalTrials.gov ID
- NCT02303496
- Acronym / sponsor ID
- PRP-CREAM-1
- Conditions
- Chronological Aging of Skin, Photoaging of Skin
- Keywords
- platelet rich plasma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- 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.
Human skin undergoes some morphological changes with the effects of chronological aging and photoaging, these are especially remarkable in the facial skin. Changes in pigmentation, sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and chronologic aging of skin. With the increasing demand, it needs to provide new approach for the prevention and treatment of these morphological changes.
Fibroblasts have a key role on skin aging. It is known that platelet rich plasma activates the fibroblasts and increases the synthesis of collagen and other type of matrix components. Because of these specialities, platelet rich plasma is thought to be effective on skin aging.
Detailed description
Clinical evaluation of the patients will be done for five times during 3 months. 0th day (Basal), 7th day, 15th day, 45th day and 105th day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Cream Application | Experimental | Biological: Platelet Rich Plasma CreamApplication of Cream Containing Platelet Rich Plasma and Oleaginous Base |
| SW Cream Application - Placebo | Active comparator | Biological: Placebo - Sterile Water CreamApplication of Cream Containing Sterile Water and Oleaginous Base |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patient has periorbital wrinkles with Glogau Scale 3 or more
Key exclusion criteria (6 listed)
- Patients with precancerous lesions
- Patients with inflammatory skin disease like rosacea, psoriasis, seborrheic eczema
- Patients with connective tissue disease like lupus erythematosus
- Patients have a cosmetic intervention to their face, like chemical peel, infrared, radio frequency, laser, fillers or botulinum toxin injections in last 6 months
- Patients who use an anti aging cream containing retinoic acid, vitamin C and peptides in last 3 months
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 |
|---|---|---|
| Platelet Rich Plasma CreamCream Containing Platelet Rich Plasma and Oleaginous Base | Biological | PRP Cream Application |
| Placebo - Sterile Water CreamCream Containing Sterile Water and Oleaginous Base | Biological | SW Cream Application - Placebo |
Primary outcome
Global efficacy evaluations and quantitative analyzes.
Time frame: T4 (105th day)
Evaluation of deep and fine wrinkling, amount of pigmentation, amount of vascularization, clarity of skin assessment done by the patient and the investigator. Quantitative analyzes: Measurements of Antera and Cutometer.
7 secondary outcomes
Deep and fine wrinkling,
Time frame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Number of Participants with Adverse Events and Type of Adverse Effects.
Time frame: T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Smell and texture of cream
Time frame: T4 (105th day)
Changes from baseline and placebo group.
Time frame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Amount of pigmentation
Time frame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Amount of vascularization
Time frame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Clarity of skin
Time frame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2014.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet Rich Plasma Cream in people with Chronological Aging of Skin and Photoaging of Skin, run by Acibadem University at 2 sites 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 1 inclusion and 6 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 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ozgur Bakar, Ass. Prof. (+905323170351, ozgurtimurkaynak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global efficacy evaluations and quantitative analyzes. (time frame: T4 (105th day)). 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 1 Dec 2014.