Platelet-Rich PlasmaNCT05096650
Platelet Rich Plasma for Treatment of Facial Photoaging: A Double-blind, Randomized, Split-face Study
A study testing mesotherapy of platelet rich plasma and platelet poor plasma in people with Platelet-Rich Plasma and Aging, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Platelet-Rich Plasma, Aging
- What is being tested?
- mesotherapy of platelet rich plasma and platelet poor plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or female patients older than 20 years old with facial photoaging (Glogau Scale type II)
- The photoaging severity of bilateral face is symmetric.
Who cannot join
- Patients with thrombocytopenia, coagulopathy, hematopoietic malignancy.
- Patients with severe inflammation over treated area, malignancy, keloid, or poor wound healing history.
- Patients had received laser, radiofrequency, ultherapy over treated area within 6 months.
- Patients had received botulism or filler injection over treated area within 12 months.
- Patients had received plastic surgery over treated area within 12 months.
- Patients had severe psychiatric disorders with poor control.
- Patients with other diseases which are not suitable for receiving platelet rich plasma (PRP) injection therapy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital
Taipei, 105
Yau-Li Huang, MD, +886-3-3196200 ext. 3712, henryhuang0219@gmail.com
About this study
Official title: Chang Gung Memorial Hospital, Taipei, Taiwan
Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. Autologous platelet-rich plasma is a preparation of platelets in concentrated plasma from peripheral blood. The α granules of platelets contained many growth factors. According to previous literature, growth factors in platelet-rich plasma directly stimulate fibroblast proliferation to boost collagen production. It has also been shown to modulate extracellular matrix metabolism and remodeling by increasing the expression of specific matrix metalloproteinases. In review of previous literatures, there was only limited researches of platelet-rich plasma for treatment of photoaging. Therefore, the present study was conducted for analyzing the efficacy and safety of autologous platelet-rich plasma in photoaging therapy.
Read the detailed description
Autologous platelet-rich plasma is a preparation of platelets in concentrated plasma from peripheral blood. The α granules of platelets contained many growth factors, such as platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, and epithelial growth factor. These growth factors can trigger intracellular signaling cascades that ultimately alter gene expression and protein synthesis. Clinically, autologous platelet-rich plasma has been applied for treatment of hair loss, chronic wounds, and atrophic scars.
Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. The therapeutic modalities of photoaging included energy-based device, filler injection, and surgical treatment. However, there are some limitations and drawbacks of these therapies. For example, filler injection may cause foreign body granuloma, vascular occlusions, or tissue necrosis. Surgical treatment is an invasive procedure which may cause hematoma, infection, or scar formation.
According to previous literature, growth factors in platelet-rich plasma directly stimulate fibroblast proliferation to boost collagen production. It has also been shown to modulate extracellular matrix metabolism and remodeling by increasing the expression of specific matrix metalloproteinases. Platelet-rich plasma-enhanced expression of matrix metalloproteinases -1 and -3 helps clear photodamaged extracellular matrix components and allow for a better quality, more organized collagen meshwork. This process helps soften fine lines and minimize scarring. In addition, transforming growth factor and epithelial growth factor in platelet-rich plasma are known to modulate keratinocyte propagation and migration as well as repair barrier function. In review of previous literatures, there was only limited researches of platelet-rich plasma for treatment of photoaging. Therefore, the present study was conducted for analyzing the efficacy and safety of autologous platelet-rich plasma in photoaging therapy.
- Conditions
- Platelet-Rich Plasma, Aging
- Being tested
- mesotherapy of platelet rich plasma and platelet poor plasma
- Keywords
- Platelet-Rich Plasma, photoaging, mesotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesotherapy of platelet rich plasma and platelet poor plasmaProcedure or surgery
Each case will receive 3 sessions of injection therapies with one month interval. Each case will receive platelet rich plasma therapy on one side of the face. The other side of the face was treated with platelet poor plasma.
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma | Experimental | Each case will receive 3 sessions of injection therapies with one month interval. The practitioner will inject 2ml of platelet rich plasma with fan and linear method into photoaging areas in one side of the midface in one session of treatment. Receives: Procedure: mesotherapy of platelet rich plasma and platelet poor plasma |
| platelet poor plasma | Other | Each case will receive 3 sessions of injection therapies with one month interval. The practitioner will inject 2ml of platelet rich plasma with fan and linear method into photoaging areas in the other side of the midface in one session of treatment. Receives: Procedure: mesotherapy of platelet rich plasma and platelet poor plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Aesthetic Improvement Scale
To assess the global aesthetic improvement in appearance compared to pretreatment (minimum: -1, worse; maximum: 3, very much improved)
Measured: 3 months after the last session of treatment
Fitzpatrick wrinkle scale
To assess the severity of wrinkles of photoaging areas (minimum: 1, mild; maximum: 9, severe)
Measured: 3 months after the last session of treatment
Wrinkle Severity Rating scale
To assess the severity of wrinkles of photoaging areas (minimum: 1, absent; maximum: 5, extreme)
Measured: 3 months after the last session of treatment
Secondary outcomes (5)
The scores of rhytids in VISIA system
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.
(minimum: 1, worse; maximum: 100, severe)
Measured: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
The scores of texture in VISIA system
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.
(minimum: 1, worse; maximum: 100, severe)
Measured: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
The scores of pores size in VISIA system
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.
(minimum: 1, worse; maximum: 100, severe)
Measured: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
The scores of pigment spots in VISIA system
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.
(minimum: 1, worse; maximum: 100, severe)
Measured: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
The scores of brownish spots in VISIA system
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.
(minimum: 1, worse; maximum: 100, severe)
Measured: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start30 Nov 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Platelet-Rich PlasmaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, split-face
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yau-Li Huang, MD, Principal investigator, Chang Gung Memorial Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096650
- Sponsor's protocol ID
- CMRPG5K0121
- Status last verified
- Sep 2021
- First submitted
- 1 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD due to the privacy of participants.
Publications
Lee ZH, Sinno S, Poudrier G, Motosko CC, Chiodo M, Saia W, Gothard D, Thomson JE, Hazen A. Platelet rich plasma for photodamaged skin: A pilot study. J Cosmet Dermatol. 2019 Feb;18(1):77-83. doi: 10.1111/jocd.12676. Epub 2018 May 31.
PubMed 29855132Cameli N, Mariano M, Cordone I, Abril E, Masi S, Foddai ML. Autologous Pure Platelet-Rich Plasma Dermal Injections for Facial Skin Rejuvenation: Clinical, Instrumental, and Flow Cytometry Assessment. Dermatol Surg. 2017 Jun;43(6):826-835. doi: 10.1097/DSS.0000000000001083.
PubMed 28375975Elnehrawy NY, Ibrahim ZA, Eltoukhy AM, Nagy HM. Assessment of the efficacy and safety of single platelet-rich plasma injection on different types and grades of facial wrinkles. J Cosmet Dermatol. 2017 Mar;16(1):103-111. doi: 10.1111/jocd.12258. Epub 2016 Jul 29.
PubMed 27474688Mehryan P, Zartab H, Rajabi A, Pazhoohi N, Firooz A. Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles. J Cosmet Dermatol. 2014 Mar;13(1):72-8. doi: 10.1111/jocd.12072.
PubMed 24641609
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chang Gung Memorial Hospital, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT05096650
- Acronym / sponsor ID
- CMRPG5K0121
- Conditions
- Platelet-Rich Plasma, Aging
- Keywords
- Platelet-Rich Plasma, photoaging, mesotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. Autologous platelet-rich plasma is a preparation of platelets in concentrated plasma from peripheral blood. The α granules of platelets contained many growth factors. According to previous literature, growth factors in platelet-rich plasma directly stimulate fibroblast proliferation to boost collagen production. It has also been shown to modulate extracellular matrix metabolism and remodeling by increasing the expression of specific matrix metalloproteinases. In review of previous literatures, there was only limited researches of platelet-rich plasma for treatment of photoaging. Therefore, the present study was conducted for analyzing the efficacy and safety of autologous platelet-rich plasma in photoaging therapy.
Detailed description
Autologous platelet-rich plasma is a preparation of platelets in concentrated plasma from peripheral blood. The α granules of platelets contained many growth factors, such as platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, and epithelial growth factor. These growth factors can trigger intracellular signaling cascades that ultimately alter gene expression and protein synthesis. Clinically, autologous platelet-rich plasma has been applied for treatment of hair loss, chronic wounds, and atrophic scars.
Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. The therapeutic modalities of photoaging included energy-based device, filler injection, and surgical treatment. However, there are some limitations and drawbacks of these therapies. For example, filler injection may cause foreign body granuloma, vascular occlusions, or tissue necrosis. Surgical treatment is an invasive procedure which may cause hematoma, infection, or scar formation.
According to previous literature, growth factors in platelet-rich plasma directly stimulate fibroblast proliferation to boost collagen production. It has also been shown to modulate extracellular matrix metabolism and remodeling by increasing the expression of specific matrix metalloproteinases. Platelet-rich plasma-enhanced expression of matrix metalloproteinases -1 and -3 helps clear photodamaged extracellular matrix components and allow for a better quality, more organized collagen meshwork. This process helps soften fine lines and minimize scarring. In addition, transforming growth factor and epithelial growth factor in platelet-rich plasma are known to modulate keratinocyte propagation and migration as well as repair barrier function. In review of previous literatures, there was only limited researches of platelet-rich plasma for treatment of photoaging. Therefore, the present study was conducted for analyzing the efficacy and safety of autologous platelet-rich plasma in photoaging therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, split-face
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma | Experimental | Procedure: mesotherapy of platelet rich plasma and platelet poor plasmaEach case will receive 3 sessions of injection therapies with one month interval. The practitioner will inject 2ml of platelet rich plasma with fan and linear method into photoaging areas in one side of the midface in one session of treatment. |
| platelet poor plasma | Other | Procedure: mesotherapy of platelet rich plasma and platelet poor plasmaEach case will receive 3 sessions of injection therapies with one month interval. The practitioner will inject 2ml of platelet rich plasma with fan and linear method into photoaging areas in the other side of the midface in one session of treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or female patients older than 20 years old with facial photoaging (Glogau Scale type II)
- The photoaging severity of bilateral face is symmetric.
Key exclusion criteria (7 listed)
- Patients with thrombocytopenia, coagulopathy, hematopoietic malignancy.
- Patients with severe inflammation over treated area, malignancy, keloid, or poor wound healing history.
- Patients had received laser, radiofrequency, ultherapy over treated area within 6 months.
- Patients had received botulism or filler injection over treated area within 12 months.
- Patients had received plastic surgery over treated area within 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesotherapy of platelet rich plasma and platelet poor plasmaEach case will receive 3 sessions of injection therapies with one month interval. Each case will receive platelet rich plasma therapy on one side of the face. The other side of the face was treated with platelet poor plasma. | Procedure or surgery | platelet poor plasma, platelet rich plasma |
Primary outcome
Global Aesthetic Improvement Scale
Time frame: 3 months after the last session of treatment
To assess the global aesthetic improvement in appearance compared to pretreatment (minimum: -1, worse; maximum: 3, very much improved)
Fitzpatrick wrinkle scale
Time frame: 3 months after the last session of treatment
To assess the severity of wrinkles of photoaging areas (minimum: 1, mild; maximum: 9, severe)
Wrinkle Severity Rating scale
Time frame: 3 months after the last session of treatment
To assess the severity of wrinkles of photoaging areas (minimum: 1, absent; maximum: 5, extreme)
5 secondary outcomes
The scores of rhytids in VISIA system
Time frame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
The scores of texture in VISIA system
Time frame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
The scores of pores size in VISIA system
Time frame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
The scores of pigment spots in VISIA system
Time frame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
The scores of brownish spots in VISIA system
Time frame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Results publication: PubMed 29855132Lee ZH, Sinno S, Poudrier G, Motosko CC, Chiodo M, Saia W, Gothard D, Thomson JE, Hazen A. Platelet rich plasma for photodamaged skin: A pilot study. J Cosmet Dermatol. 2019 Feb;18(1):77-83. doi: 10.1111/jocd.12676. Epub 2018 May 31.
- Results publication: PubMed 28375975Cameli N, Mariano M, Cordone I, Abril E, Masi S, Foddai ML. Autologous Pure Platelet-Rich Plasma Dermal Injections for Facial Skin Rejuvenation: Clinical, Instrumental, and Flow Cytometry Assessment. Dermatol Surg. 2017 Jun;43(6):826-835. doi: 10.1097/DSS.0000000000001083.
- Results publication: PubMed 27474688Elnehrawy NY, Ibrahim ZA, Eltoukhy AM, Nagy HM. Assessment of the efficacy and safety of single platelet-rich plasma injection on different types and grades of facial wrinkles. J Cosmet Dermatol. 2017 Mar;16(1):103-111. doi: 10.1111/jocd.12258. Epub 2016 Jul 29.
- Results publication: PubMed 24641609Mehryan P, Zartab H, Rajabi A, Pazhoohi N, Firooz A. Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles. J Cosmet Dermatol. 2014 Mar;13(1):72-8. doi: 10.1111/jocd.12072.
- Individual participant dataSharing planned: No. We will not share IPD due to the privacy of participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yau-Li Huang, MD principal investigator
Chang Gung Memorial Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mesotherapy of platelet rich plasma and platelet poor plasma in people with Platelet-Rich Plasma and Aging, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yau-Li Huang, MD (+886-3-3196200 ext. 3712, henryhuang0219@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement Scale (time frame: 3 months after the last session of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096650, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.