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

NCT ID: NCT02303496

Last Updated: 2014-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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

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Chronological Aging of Skin Photoaging of Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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PRP Cream Application

Application of Cream Containing Platelet Rich Plasma and Oleaginous Base

Group Type EXPERIMENTAL

Platelet Rich Plasma Cream

Intervention Type BIOLOGICAL

Cream Containing Platelet Rich Plasma and Oleaginous Base

SW Cream Application - Placebo

Application of Cream Containing Sterile Water and Oleaginous Base

Group Type ACTIVE_COMPARATOR

Placebo - Sterile Water Cream

Intervention Type BIOLOGICAL

Cream Containing Sterile Water and Oleaginous Base

Interventions

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Platelet Rich Plasma Cream

Cream Containing Platelet Rich Plasma and Oleaginous Base

Intervention Type BIOLOGICAL

Placebo - Sterile Water Cream

Cream Containing Sterile Water and Oleaginous Base

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Ercument Ovali

Specialist, Haematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Acibadem Labcell

Istanbul, Fahrettin Kerim Gokay Saint No:49, Turkey (Türkiye)

Site Status

Acibadem Kozyatagi Hospital

Istanbul, Inonu Saint No.20 Kozyatagi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Ozgur Bakar, Ass. Prof.

Role: CONTACT

+905323170351

Ercument Ovali, Prof.Dr.

Role: CONTACT

+905325729174

Facility Contacts

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Ercument Ovali, Prof.Dr.

Role: primary

+905325729174

Fatma Eyuboglu Unuvar, Msc.

Role: backup

+905413091649

Ozgur Bakar, Ass. Prof.

Role: primary

++905323170351

Other Identifiers

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PRP-CREAM-1

Identifier Type: -

Identifier Source: org_study_id