Clinical trial NCT06319768: Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined Pentoxifylline With Platelet-Rich Plasma in Patients With Atrophic Acne Scars
Official title: Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrophic Acne Scar
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: goodman and baron qualitative grading system of postacne scarring
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Alves R, Grimalt R. Platelet-Rich Plasma and its Use for Cicatricial and Non-Cicatricial Alopecias: A Narrative Review. Dermatol Ther (Heidelb). 2020 Aug;10(4):623-633. doi: 10.1007/s13555-020-00408-5. Epub 2020 Jun 17.
citation: Balazic E, Axler E, Konisky H, Khanna U, Kobets K. Pentoxifylline in dermatology. J Cosmet Dermatol. 2023 Feb;22(2):410-417. doi: 10.1111/jocd.15445. Epub 2022 Oct 31.
citation: Bhargava S, Kroumpouzos G, Varma K, Kumar U. Combination therapy using subcision, needling, and platelet-rich plasma in the management of grade 4 atrophic acne scars: A pilot study. J Cosmet Dermatol. 2019 Aug;18(4):1092-1097. doi: 10.1111/jocd.12935. Epub 2019 Mar 28.
citation: Connolly D, Vu HL, Mariwalla K, Saedi N. Acne Scarring-Pathogenesis, Evaluation, and Treatment Options. J Clin Aesthet Dermatol. 2017 Sep;10(9):12-23. Epub 2017 Sep 1.