Clinical trial NCT02303496: Autologous Platelet-Rich Plasma Cream for Photoaging and Chronological Skin Aging
Official title: The Effects of Autologous Platelet-Rich Plasma Cream on Photoaging and Chronological Skin Aging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronological Aging of Skin
Photoaging of Skin
Keywords: platelet rich plasma
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2014-12-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global efficacy evaluations and quantitative analyzes.
timeFrame: T4 (105th day)
Secondary outcomes:
measure: Deep and fine wrinkling,
timeFrame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
measure: Number of Participants with Adverse Events and Type of Adverse Effects.
timeFrame: T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
measure: Smell and texture of cream
timeFrame: T4 (105th day)
measure: Changes from baseline and placebo group.
timeFrame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
measure: Amount of pigmentation
timeFrame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
measure: Amount of vascularization
timeFrame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
measure: Clarity of skin
timeFrame: T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Labcell
state: Fahrettin Kerim Gokay St. No:49
city: Istanbul
country: Turkey
facility: Acibadem Kozyatagi Hospital
state: Inonu St. No.20 Kozyatagi
Study officials:
References: