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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP Cream Application | Experimental | Application of Cream Containing Platelet Rich Plasma and Oleaginous Base |
|
| SW Cream Application - Placebo | Active Comparator | Application of Cream Containing Sterile Water and Oleaginous Base |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma Cream | Biological | Cream Containing Platelet Rich Plasma and Oleaginous Base |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Participants with Adverse Events and Type of Adverse Effects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ozgur Bakar, Ass. Prof. | Contact | +905323170351 | ozgurtimurkaynak@hotmail.com | |
| Ercument Ovali, Prof.Dr. | Contact | +905325729174 | ercument.ovali@acibademlabcell.com.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acibadem Labcell | Istanbul | Fahrettin Kerim Gokay Saint No:49 | 34662 | Turkey (Türkiye) |
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| Placebo - Sterile Water Cream | Biological | Cream Containing Sterile Water and Oleaginous Base |
|
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Acibadem Kozyatagi Hospital | Istanbul | Inonu Saint No.20 Kozyatagi | 34742 | Turkey (Türkiye) |
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