Platelet-Rich PlasmaPhase 3NCT03859843
Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris
A Phase 3 study testing PRP, Chemical peeling (Salycilic acid) and Chemical peeling (Jessener's solution) in people with Platelet-Rich Plasma and Acne Vulgaris, run by Assiut University.
Trial summary
Efficacy and Antimicrobial activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A randomized controlled trial Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Platelet-Rich Plasma, Acne Vulgaris
- What is being tested?
- PRP, Chemical peeling (Salycilic acid) and Chemical peeling (Jessener's solution)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2020to 10 May 2022
- Phase
- Phase 3
- 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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with active acne vulgaris lesions (inflammatory and non-inflammatory).
- Age range from 14 to 40 years.
- Patients with any topical and systemic treatments will undergo wash out period of one month.
Who cannot join
- Patients with herpes labials, or bacterial infection; warts on the face, actinic keratosis, or skin cancer or allergy to medications.
- Systemic retinoids intake in the previous 6 months
- History of keloidal scarring.
- Patients on anticoagulant therapy or aspirin or have a coagulation issue,
- Patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l
- Pregnant women
- Immunocompromised patients
- Patients with medical diseases like diabetes mellitus, epilepsy or malignancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A Randomized Controlled Trial
Efficacy and Antimicrobial activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A randomized controlled trial
Read the detailed description
Acne vulgaris is one of the most common chronic skin diseases worldwide. The condition usually starts in adolescence, peaks at the ages of 14 to 19 years and frequently resolves by mid-twenties.
Acne is characterized by seborrhea, formation of open and closed comedones, erythematous papules and pustules and in more severe cases present with nodules, deep pustules and pseudo cysts, in many cases a degree of scarring will ensue.
Its pathophysiology includes hyperseborrhoea, abnormal follicular keratinization and Propionibacterium acnes proliferation in the pilosebaceous unit.
Acne is a significant clinical problem with sever social, psychological, and emotional implications. A mainly genetically determined host response pattern combined with bacterial ''triggering'' is generally accepted as being important for the apparently unbalanced inflammatory activity.
Acne is not an infectious disease, but three major organisms were isolated from the surface of the skin and the pilosebaceous duct of patients with acne including Propionibacterium acne, Staphylococcus epidermidis and Malassezia furfur.
Platelet rich plasma is a good choice for the treatment of acne and atrophic scars reminiscent of the course of the disease. In addition, for being autologous, it reduces the possibility of side effects, such as skin dryness and rejection.
It was demonstrated that PRP accelerates the healing process, regulates inflammation and promotes healing by inhibiting the P. acnes bacteria, additionally restoring collagen). The PRP's mechanism of action also involves the release of powerful antimicrobial peptides from the platelets' alpha granules.
Although there are few studies on the PRP's effectiveness in acne, it emerges as a potential therapeutic option in Dermatology and Aesthetic Medicine.
Due to development of resistance in microorganisms causing acne to common antibiotics and differences in species and strains of the microorganisms in different regions, this study will be undertaken to determine bacteria involve in acne vulgaris and the effect of PRP on it.
- Conditions
- Platelet-Rich Plasma, Acne Vulgaris
- Being tested
- PRP, Chemical peeling (Salycilic acid), Chemical peeling (Jessener's solution)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPCombination product
Ten mL of venous blood will be drawn in a syringe fill with 1.5 mL of anticoagulant solution (anticoagulant citrate dextrose solution formula A, Baxter, Deerfield, IL). The blood will be centrifuged at 160 g for 10 minutes. After the first spin, the lower red blood cell portion will be discarded, and the supernatant will be centrifuged at 400 g for 10 minutes. The resulting pellet of platelets will be mixed with 1.5 mL of supernatant, which make 1.5 mL of PRP. One mL of 3% calcium chloride will be added to the PRP to induce platelet activation.
Chemical peeling (Salycilic acid)Other
SA is a 2-hydroxybenzoic acid (from willow tree) used for superficial peeling due to its strong keratolytic and comedo- lytic properties. It promotes shedding of epidermal cells and due to its lipophilic properties can penetrate comedones and pores to prevent clogging and neutralize bacteria. It promotes desquamation of the upper lipophilic layers of the stratum corneum.19 These chemical properties explain its popularity and success in acne patients.It also has well- documented anti-inflammatory properties.
Chemical peeling (Jessener's solution)Other
is a superficial peeling agent used as adjuvant therapy for acne. it is generally proposed to break of the hydrogen bonds of keratin (keratolysis), disruption of cell membranes (cell death) and is bactericidal.
| Study group | Role | What they receive |
|---|---|---|
| PRP | Active comparator | Not described Receives: Combination Product: PRP |
| Chemical peeling (Salycilic acid) | Active comparator | Not described Receives: Other: Chemical peeling (Salycilic acid) |
| Chemical peeling (Jessenr's solution) | Active comparator | Not described Receives: Other: Chemical peeling (Jessener's solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Assess cure rate of PRP and Chemical peeling agents in treatment of Aactive Acne Vulgaris in 3 months duration and compare efficacy of all measures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start10 Jan 2020 (estimated)
- Primary completion10 Jan 2021 (estimated)
- Study completion10 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-Rich PlasmaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiba A H alshaaby, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859843
- Sponsor's protocol ID
- PRP in Acne Vulgaris
- Status last verified
- Feb 2019
- First submitted
- 28 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03859843
- Acronym / sponsor ID
- PRP in Acne Vulgaris
- Conditions
- Platelet-Rich Plasma, Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (estimated)
- Primary completion
- 10 Jan 2021 (estimated)
- Study completion
- 10 May 2022 (estimated)
- First posted
- 1 Mar 2019 (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.
Efficacy and Antimicrobial activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A randomized controlled trial
Detailed description
Acne vulgaris is one of the most common chronic skin diseases worldwide. The condition usually starts in adolescence, peaks at the ages of 14 to 19 years and frequently resolves by mid-twenties.
Acne is characterized by seborrhea, formation of open and closed comedones, erythematous papules and pustules and in more severe cases present with nodules, deep pustules and pseudo cysts, in many cases a degree of scarring will ensue.
Its pathophysiology includes hyperseborrhoea, abnormal follicular keratinization and Propionibacterium acnes proliferation in the pilosebaceous unit.
Acne is a significant clinical problem with sever social, psychological, and emotional implications. A mainly genetically determined host response pattern combined with bacterial ''triggering'' is generally accepted as being important for the apparently unbalanced inflammatory activity.
Acne is not an infectious disease, but three major organisms were isolated from the surface of the skin and the pilosebaceous duct of patients with acne including Propionibacterium acne, Staphylococcus epidermidis and Malassezia furfur.
Platelet rich plasma is a good choice for the treatment of acne and atrophic scars reminiscent of the course of the disease. In addition, for being autologous, it reduces the possibility of side effects, such as skin dryness and rejection.
It was demonstrated that PRP accelerates the healing process, regulates inflammation and promotes healing by inhibiting the P. acnes bacteria, additionally restoring collagen). The PRP's mechanism of action also involves the release of powerful antimicrobial peptides from the platelets' alpha granules.
Although there are few studies on the PRP's effectiveness in acne, it emerges as a potential therapeutic option in Dermatology and Aesthetic Medicine.
Due to development of resistance in microorganisms causing acne to common antibiotics and differences in species and strains of the microorganisms in different regions, this study will be undertaken to determine bacteria involve in acne vulgaris and the effect of PRP on it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP | Active comparator | Combination Product: PRP |
| Chemical peeling (Salycilic acid) | Active comparator | Other: Chemical peeling (Salycilic acid) |
| Chemical peeling (Jessenr's solution) | Active comparator | Other: Chemical peeling (Jessener's solution) |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with active acne vulgaris lesions (inflammatory and non-inflammatory).
- Age range from 14 to 40 years.
- Patients with any topical and systemic treatments will undergo wash out period of one month.
Key exclusion criteria (8 listed)
- Patients with herpes labials, or bacterial infection; warts on the face, actinic keratosis, or skin cancer or allergy to medications.
- Systemic retinoids intake in the previous 6 months
- History of keloidal scarring.
- Patients on anticoagulant therapy or aspirin or have a coagulation issue,
- Patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l
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 |
|---|---|---|
| PRPTen mL of venous blood will be drawn in a syringe fill with 1.5 mL of anticoagulant solution (anticoagulant citrate dextrose solution formula A, Baxter, Deerfield, IL). The blood will be centrifuged at 160 g for 10 minutes. After the first spin, the lower red blood cell portion will be discarded, and the supernatant will be centrifuged at 400 g for 10 minutes. The resulting pellet of platelets will be mixed with 1.5 mL of supernatant, which make 1.5 mL of PRP. One mL of 3% calcium chloride will be added to the PRP to induce platelet activation. | Combination product | PRP |
| Chemical peeling (Salycilic acid)SA is a 2-hydroxybenzoic acid (from willow tree) used for superficial peeling due to its strong keratolytic and comedo- lytic properties. It promotes shedding of epidermal cells and due to its lipophilic properties can penetrate comedones and pores to prevent clogging and neutralize bacteria. It promotes desquamation of the upper lipophilic layers of the stratum corneum.19 These chemical properties explain its popularity and success in acne patients.It also has well- documented anti-inflammatory properties. | Other | Chemical peeling (Salycilic acid) |
| Chemical peeling (Jessener's solution)is a superficial peeling agent used as adjuvant therapy for acne. it is generally proposed to break of the hydrogen bonds of keratin (keratolysis), disruption of cell membranes (cell death) and is bactericidal. | Other | Chemical peeling (Jessenr's solution) |
Primary outcome
Cure rate
Time frame: 3 months
Assess cure rate of PRP and Chemical peeling agents in treatment of Aactive Acne Vulgaris in 3 months duration and compare efficacy of all measures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRP, Chemical peeling (Salycilic acid) and Chemical peeling (Jessener's solution) in people with Platelet-Rich Plasma and Acne Vulgaris, run by Assiut University.
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 3 inclusion and 8 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sara Awad, PhD (+20 102 3102094, saramawad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2019.