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

Photoaging of Skin Clinical Trial

Official title:

The Effects of Autologous Platelet-Rich Plasma Cream on Photoaging and Chronological Skin Aging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02303496
• Other study ID #: PRP-CREAM-1
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: November 14, 2014
• Last updated: November 25, 2014
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2014
• Source: Acibadem University
• Contact: Ozgur Bakar, Ass. Prof.
• Phone: +905323170351
• Email: ozgurtimurkaynak[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronological Aging of Skin
• Photoaging of Skin

Intervention

Biological:
• Platelet Rich Plasma Cream
Cream Containing Platelet Rich Plasma and Oleaginous Base
• Placebo - Sterile Water Cream
Cream Containing Sterile Water and Oleaginous Base

Locations

Country	Name	City	State
Turkey	Acibadem Kozyatagi Hospital	Istanbul	Inonu St. No.20 Kozyatagi
Turkey	Acibadem Labcell	Istanbul	Fahrettin Kerim Gokay St. No:49

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes