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

Primary Purpose

Chronological Aging of Skin, Photoaging of Skin

Status
Unknown status
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Platelet Rich Plasma Cream
Placebo - Sterile Water Cream
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronological Aging of Skin focused on measuring platelet rich plasma

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Acibadem Labcell
  • Acibadem Kozyatagi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRP Cream Application

SW Cream Application - Placebo

Arm Description

Application of Cream Containing Platelet Rich Plasma and Oleaginous Base

Application of Cream Containing Sterile Water and Oleaginous Base

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Deep and fine wrinkling,
It will be scored from 0 to 10, by patients and the investigator
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
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)
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.
Amount of pigmentation
It will be scored from 0 to 10, by patients and the investigator
Amount of vascularization
It will be scored from 0 to 10, by patients and the investigator
Clarity of skin
It will be scored from 0 to 10, by patients and the investigator

Full Information

First Posted
November 14, 2014
Last Updated
November 25, 2014
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT02303496
Brief Title
Autologous Platelet-Rich Plasma Cream for Photoaging and Chronological Skin Aging
Official Title
The Effects of Autologous Platelet-Rich Plasma Cream on Photoaging and Chronological Skin Aging
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronological Aging of Skin, Photoaging of Skin
Keywords
platelet rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP Cream Application
Arm Type
Experimental
Arm Description
Application of Cream Containing Platelet Rich Plasma and Oleaginous Base
Arm Title
SW Cream Application - Placebo
Arm Type
Active Comparator
Arm Description
Application of Cream Containing Sterile Water and Oleaginous Base
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma Cream
Intervention Description
Cream Containing Platelet Rich Plasma and Oleaginous Base
Intervention Type
Biological
Intervention Name(s)
Placebo - Sterile Water Cream
Intervention Description
Cream Containing Sterile Water and Oleaginous Base
Primary Outcome Measure Information:
Title
Global efficacy evaluations and quantitative analyzes.
Description
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.
Time Frame
T4 (105th day)
Secondary Outcome Measure Information:
Title
Deep and fine wrinkling,
Description
It will be scored from 0 to 10, by patients and the investigator
Time Frame
T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Title
Number of Participants with Adverse Events and Type of Adverse Effects.
Description
Clinical evaluation of erythema, edema, xerosis, scaling. Each item will be scored from 0 to 3 by investigator
Time Frame
T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Title
Smell and texture of cream
Description
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)
Time Frame
T4 (105th day)
Title
Changes from baseline and placebo group.
Description
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.
Time Frame
T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Title
Amount of pigmentation
Description
It will be scored from 0 to 10, by patients and the investigator
Time Frame
T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Title
Amount of vascularization
Description
It will be scored from 0 to 10, by patients and the investigator
Time Frame
T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Title
Clarity of skin
Description
It will be scored from 0 to 10, by patients and the investigator
Time Frame
T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozgur Bakar, Ass. Prof.
Phone
+905323170351
Email
ozgurtimurkaynak@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ercument Ovali, Prof.Dr.
Phone
+905325729174
Email
ercument.ovali@acibademlabcell.com.tr
Facility Information:
Facility Name
Acibadem Labcell
City
Istanbul
State/Province
Fahrettin Kerim Gokay St. No:49
ZIP/Postal Code
34662
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ercument Ovali, Prof.Dr.
Phone
+905325729174
Email
ercument.ovali@acibademlabcell.com.tr
First Name & Middle Initial & Last Name & Degree
Fatma Eyuboglu Unuvar, Msc.
Phone
+905413091649
Email
fteyuboglu@gmail.com
Facility Name
Acibadem Kozyatagi Hospital
City
Istanbul
State/Province
Inonu St. No.20 Kozyatagi
ZIP/Postal Code
34742
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozgur Bakar, Ass. Prof.
Phone
++905323170351
Email
ozgurtimurkaynak@hotmail.com

12. IPD Sharing Statement

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

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