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

Phase 1

• Conditions: Chronological Aging of Skin; Photoaging of Skin

• Registration Number: NCT02303496
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Status Verified: 2014-11
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-25
• Last Update Submitted: 2014-11-25
• Study Start: 2014-12
• Study First Posted: 2014-12-01
• Last Update Posted: 2014-12-01
• Primary Completion: 2015-03
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Global efficacy evaluations and quantitative analyzes.	T4 (105th day)	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

Name	Time	Method
Number of Participants with Adverse Events and Type of Adverse Effects.	T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)	Clinical evaluation of erythema, edema, xerosis, scaling. Each item will be scored from 0 to 3 by investigator
Deep and fine wrinkling,	T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)	It will be scored from 0 to 10, by patients and the investigator
Amount of vascularization	T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)	It will be scored from 0 to 10, by patients and the investigator
Clarity of skin	T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)	It will be scored from 0 to 10, by patients and the investigator
Smell and texture of cream	T4 (105th day)	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.	T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)	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	T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)	It will be scored from 0 to 10, by patients and the investigator

Trial Locations

Locations (2)

Acibadem Labcell; 🇹🇷 Istanbul, Fahrettin Kerim Gokay St. No:49, Turkey

Acibadem Kozyatagi Hospital; 🇹🇷 Istanbul, Inonu St. No.20 Kozyatagi, Turkey