A Phase 1/2 interventional study of Platelet Rich Plasma Cream and Placebo - Sterile Water Cream in Chronological Aging of Skin and Photoaging of Skin, sponsored by Acibadem University. Status unknown at 2 sites in Turkey. Open to female participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-01.
Sponsored by Acibadem University · Phase 1/2, Interventional, and Treatment
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.
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.
538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 372 interventional studies indexed under Skin Diseases.
Browse Skin Diseases studies →Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Application of Cream Containing Platelet Rich Plasma and Oleaginous Base
Biological: Platelet Rich Plasma Cream
Application of Cream Containing Sterile Water and Oleaginous Base
Biological: Placebo - Sterile Water Cream
Cream Containing Platelet Rich Plasma and Oleaginous Base
Cream Containing Sterile Water and Oleaginous Base
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.
Time frame: T4 (105th day)
Deep and fine wrinkling,
It will be scored from 0 to 10, by patients and the investigator
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Acibadem University