Chronological Aging of Skin, Photoaging of Skin
Conditions
Keywords
platelet rich plasma
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.
Interventions
BIOLOGICALPlatelet Rich Plasma Cream
Cream Containing Platelet Rich Plasma and Oleaginous Base
BIOLOGICALPlacebo - Sterile Water Cream
Cream Containing Sterile Water and Oleaginous Base
Sponsors
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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 |
Countries
Turkey (Türkiye)
Contacts
Primary ContactOzgur Bakar, Ass. Prof.
Backup ContactErcument Ovali, Prof.Dr.
Outcome results
None listed