NCT02303496

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 1, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

November 14, 2014

Last Update Submit

November 25, 2014

Conditions

Chronological Aging of SkinPhotoaging of Skin

Keywords

platelet rich plasma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Deep and fine wrinkling,

    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.

    T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)

  • Smell and texture of cream

    T4 (105th day)

  • Changes from baseline and placebo group.

    T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)

  • Amount of pigmentation

    T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)

  • +2 more secondary outcomes

Study Arms (2)

PRP Cream Application

EXPERIMENTAL

Application of Cream Containing Platelet Rich Plasma and Oleaginous Base

Biological: Platelet Rich Plasma Cream

SW Cream Application - Placebo

ACTIVE COMPARATOR

Application of Cream Containing Sterile Water and Oleaginous Base

Biological: Placebo - Sterile Water Cream

Interventions

Platelet Rich Plasma CreamBIOLOGICAL

Cream Containing Platelet Rich Plasma and Oleaginous Base

PRP Cream Application
Placebo - Sterile Water CreamBIOLOGICAL

Cream Containing Sterile Water and Oleaginous Base

SW Cream Application - Placebo

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Acibadem Labcell

Istanbul, Fahrettin Kerim Gokay Saint No:49, 34662, Turkey (Türkiye)

Location

Acibadem Kozyatagi Hospital

Istanbul, Inonu Saint No.20 Kozyatagi, 34742, Turkey (Türkiye)

Location

Central Study Contacts

Ozgur Bakar, Ass. Prof.

CONTACT

+905323170351ozgurtimurkaynak@hotmail.com

Ercument Ovali, Prof.Dr.

CONTACT

+905325729174ercument.ovali@acibademlabcell.com.tr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, Haematology

Study Record Dates

First Submitted

November 14, 2014

First Posted

December 1, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

December 1, 2014

Record last verified: 2014-11

Locations

TU(2)