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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281782
• Other study ID #: PRP with topical retinoids
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Howida Omar Twisy
• Phone: +201029512930
• Email: d.howida[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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