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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronological Aging of Skin, Photoaging of Skin

Intervention / Treatment
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* Biological: Platelet Rich Plasma Cream
* Biological: Placebo - Sterile Water Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP Cream Application<br>Application of Cream Containing Platelet Rich Plasma and Oleaginous Base | Biological: Platelet Rich Plasma Cream<br>* Cream Containing Platelet Rich Plasma and Oleaginous Base<br>|
| Active Comparator: SW Cream Application - Placebo<br>Application of Cream Containing Sterile Water and Oleaginous Base | Biological: Placebo - Sterile Water Cream<br>* Cream Containing Sterile Water and Oleaginous Base<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich plasma