Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris

Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris: Randomized Clinical Trial

Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.

Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .

Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.

Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.

For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.

PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment.

Study Overview

• Status: Recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: topical retinoids and platalet rich plasma

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Howida Omar Twisy; Phone Number: egypt +201029512930; Email: d.howida@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Faculty of medicine
    • Contact: Howida Abdalla; Email: d.howida@windowslive.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with facial acne vulgaris
• Age from 12 to 35 years old

Exclusion Criteria:

• Pregnant or lactating women.
• patients with history of coagulation disorders.
• chronic diseases (chronic renal failure, hepatic insufficiency, cardiovascular disorders, uncontrolled diabetes mellitus, thyroid disorders, anemia, autoimmune diseases).
• patients with unrealistic expectations.
• Patients received any systemic treatment in the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: topical retinoid and platelet-rich plasma (PRP) group	Other: topical retinoids and platalet rich plasma; We will analyse both monotherapy with a topical retinoid alone and combination therapy with a topical retinoid and platelet-rich plasma (PRP) to elucidate their role in acne treatment and provide possible recommendations for their use.
Active Comparator: topical retinoid group	Other: topical retinoids and platalet rich plasma; We will analyse both monotherapy with a topical retinoid alone and combination therapy with a topical retinoid and platelet-rich plasma (PRP) to elucidate their role in acne treatment and provide possible recommendations for their use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of acne lasions	record percentage of improvement for each patient after completion of the treatment by comparing before and after digital photographs according to quartile grading scale	after 1 month of treatment completion

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: PRP with topical retinoids

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No