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

NCT06281782 | Recruiting

• 1 other identifier: PRP with topical retinoids
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

topical retinoid and platelet-rich plasma (PRP) group

ACTIVE COMPARATOR

Other: topical retinoids and platalet rich plasma

topical retinoid group

ACTIVE COMPARATOR

Other: topical retinoids and platalet rich plasma

Interventions

topical retinoids and platalet rich plasma OTHER

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.

topical retinoid and platelet-rich plasma (PRP) group; topical retinoid group

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Retinoids

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Central Study Contacts

Howida Omar Twisy

CONTACT

+201029512930; d.howida@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Topical retinoids versus topical retinoids wit PRP in acne vulgaris treatment

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)