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

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: Unknown
• Conditions: Photoaging of Skin; Chronological Aging of Skin
• Intervention / Treatment: Biological: Platelet Rich Plasma Cream; Biological: Placebo - Sterile Water Cream

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	T4 (105th day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deep and fine wrinkling,	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.	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	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.	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	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	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	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

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Estimate): December 1, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: platelet rich plasma
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: PRP-CREAM-1