NCT03859843

Brief Summary

Efficacy and Antimicrobial activity of Platelet Rich Plasma (PRP) in Acne Vulgaris : A randomized controlled trial

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 28, 2019

Last Update Submit

March 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Study Arms (3)

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)

Interventions

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.

PRP

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 (Salycilic acid)

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.

Chemical peeling (Jessenr's solution)

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Chemexfoliation

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsDermatologic Surgical ProceduresPlastic Surgery ProceduresSurgical Procedures, Operative

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 1, 2019

Study Start

January 10, 2020

Primary Completion

January 10, 2021

Study Completion

May 10, 2022

Last Updated

March 5, 2019

Record last verified: 2019-02