Autologous Platelet-Rich Plasma Cream for Photoaging and Chronological Skin Aging

November 25, 2014 updated by: Ercument Ovali, Acibadem University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Fahrettin Kerim Gokay St. No:49
      • Istanbul, Fahrettin Kerim Gokay St. No:49, Turkey, 34662
        • Acibadem Labcell
    • Inonu St. No.20 Kozyatagi
      • Istanbul, Inonu St. No.20 Kozyatagi, Turkey, 34742
        • Acibadem Kozyatagi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The patient has periorbital wrinkles with Glogau Scale 3 or more

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PRP Cream Application
Application of Cream Containing Platelet Rich Plasma and Oleaginous Base
Biological: Platelet Rich Plasma Cream
Cream Containing Platelet Rich Plasma and Oleaginous Base
Active Comparator: SW Cream Application - Placebo
Application of Cream Containing Sterile Water and Oleaginous Base
Biological: Placebo - Sterile Water Cream
Cream Containing Sterile Water and Oleaginous Base

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
T4 (105th day)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Deep and fine wrinkling,
Time Frame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
It will be scored from 0 to 10, by patients and the investigator
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)
Clinical evaluation of erythema, edema, xerosis, scaling. Each item will be scored from 0 to 3 by investigator
T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Smell and texture of cream
Time Frame: T4 (105th day)
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)
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)
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.
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)
It will be scored from 0 to 10, by patients and the investigator
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)
It will be scored from 0 to 10, by patients and the investigator
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)
It will be scored from 0 to 10, by patients and the investigator
T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRP-CREAM-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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