Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined Pentoxifylline With Platelet-Rich Plasma in Patients With Atrophic Acne Scars

Sohag University

Status: Enrolling

Conditions: Atrophic Acne Scar

Treatments: Drug: Pentoxifylline; Drug: combined pentoxifylline and platelet rich plasma; Drug: platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT06319768

soh-med-24-01-04ms

Details and patient eligibility

About

Platelet-rich plasma (PRP) is an Acne vulgaris is a common chronic inflammatory skin disorder. It is the eighth most prevalent disease worldwide with a prevalence of 9.4%. Acne scar is one of the most persistent complications of acne, causes marked psychological stress to the patient . The process of acne scar formation can be broadly divided into two stages: increased tissue formation and loss or damage of tissue, corresponding to keloid or hypertrophic scar and atrophic scar, respectively.

The ultimate severity of acne scars is correlated with acne grade and the delay in treatment of active disease. The atrophic scars include three subtypes: icepick or V-shaped, rolling or M-shaped, and boxcar or U-shaped scars. Among atrophic scars, the ice pick type represents 60%-70%; the boxcar type represents 20%-30%; and the rolling type represents 15%-25% (Salameh and Shumaker, 2022). According to the qualitative scarring grading system, a macular acne scar type also exists, which clinically shows erythematous, hyperpigmented, or hypopigmented flat marks.

autologous blood product containing high concentrations of platelets in a small volume of plasma. PRP has been utilized in the treatment of orthopedic, musculoskeletal, and maxillofacial conditions for many years, it has only recently gained popularity in dermatology. PRP contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TFG), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). These growth factors stimulate tissue remodeling and are associated with enhanced healing through the attraction of macrophages, upregulation of collagen synthesis, and promotion of tissue regeneration. Moreover, platelet-derived growth factor (PDGF) was shown to promote wound healing, angiogenesis, and tissue remodeling.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged > 18 years old.
• Both sexes.
• All types of atrophic acne scars

Exclusion criteria

• • Pregnant or lactating women.

  • Coagulation disorders or anemia.
  • Skin infections.
  • Patients with hormonal disturbance.
  • Chronic disease e.g: diabetes, renal disease....etc.
  • Refusal to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

- In group A (PTX group) (n:25):

Active Comparator group

Description:

Patients will be treated with intralesional PTX (Trentoximal Ampoule 100 mg/5 ml) in a dose of 1mg per lesion at a distance 1cm between two atrophic lesions with a maximum 20 mg per session (with insulin syringe 30Gx8mm). Lesion blanching is the endpoint of injection.

Treatment:

Drug: Pentoxifylline

- In group B(PRP group) (n:25):

Active Comparator group

Description:

Patients will be treated with intralesional PRP. PRP will be obtained by the double-spin method, followed by the collection of 10 mL of autologous whole blood into tubes containing trisodium citrate as an anticoagulant. The collected blood will first be centrifuged at 1000 RPM for 10 minutes at room temperature to separate the red blood cells at the bottom of the tube, the buffy coat (containing the white blood cells) in the middle, and the plasma above (soft spin). Then, the upper plasma will be pipetted above the buffy coat to undergo another centrifugation at 1500 RPM for another10 minutes (hard spin) to obtain a platelet pellet in the bottom of the tube (with a platelet count 4-4.5 times higher than that of baseline) and a platelet-poor plasma(PPP) in the upper part. The PPP will be partly removed and partly used to re-suspend the platelets to finally produce 2 mL of PRP.

Treatment:

Drug: platelet rich plasma

- In group C (combined PTX & PRP) (n:25):

Active Comparator group

Description:

Patients will be treated with a combination of both intralesional 1mg of PTX per lesion (with a maximum 20mg per session) then 0.1ml of intralesional PRP at the same lesion after 5 minutes.

Treatment:

Drug: combined pentoxifylline and platelet rich plasma