Viewing Study NCT06151041



Ignite Creation Date: 2024-05-06 @ 7:50 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06151041
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-11-30
First Post: 2023-05-26

Brief Title: Microneedling Combined With Either Tranexamic Acid or PRP in Treatment of Pigmented Postacne Scars
Sponsor: Assiut University
Organization: Assiut University

Study Overview

Official Title: Microneedling Combined With Either Tranexamic Acid or PRP in Treatment of Pigmented Postacne Scars A Split Face Comparative Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To evaluate the efficacy of Microneedling combined with Tranxemic acid compared with Micronedlling with PRP in treatment of Pigmented Post Acne Scars
Detailed Description: Acne is a multifactorial chronic inflammatory disease of pilosebaceous unit clinically characterised by the presence of comedones inflammatory papules pustules and sometimes nodules and cysts It commonly occurs during adolescence and cause great psychological stress Unfortunately acne scarring is common and occurs easily in the course of the disease It is one of the most common causes of facial scarring and treating acne scar is one of the most challenging cosmetic procedures Patient with acne vulgaries is not only experience the primary inflammatory and non-inflammatory lesions but also have secondary lesions such as scars excoriations post-inflammatory erythema and dyspigmentation Acne scars are pleomorphic and difficult to count or even photograph and consensus concerning acne scar nomenclature and classification remains a matter of debate

The pathophysiology driving acne scar development is attributed to an altered wound healing response initiated by cutaneous inflammation leading to an imbalance in matrix degradation and collagen biosynthesis

The ultimate severity is correlated with acne grade and delay in treatment of active disease The end result is either an excess of collagen that manifests as hypertrophickeloid scars or more commonly decreased collagen deposition that manifests as atrophic acne scars in 80 to 90 percent of cases

Tranexamic acid TXA a plasmin inhibitor used to prevent fibrinolysis to reduce blood loss is now gaining popularity as a depigmenting agent as it can block melanin synthesis in melanocytes by inhibiting plasmin-plasminogen system as well as competitive-inhibition of tyrosinase activity due to its similarity to tyrosine structure

Microneedling has been used to treat various dermatologic conditions including scars rhytides and dyschromia The treatment causes small channels of epidermal and dermal injury through the use of needles that puncture the skin The damaged collagen is removed and new growth and remodeling subsequently occur The release of platelet-derived growth factors fibroblasts and elastic fiber formation contribute to neovascularization and neocollagenesis

Ultimately this improves the appearance of scars especially atrophic scars Since microneedling minimally alters the epidermis there are limited adverse effects and downtime compared to more invasive

PRP consists of the patients own plasma that is enriched with a concentration of platelets that exceeds normal levels It also 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

Microneedling has been known to be an effective treatment option for acne scars however the addition of PRP has only recently been investigated The upregulation of growth factors associated with PRP is believed to augment the effects of microneedling to promote aesthetically superior tissue remodeling Their synergistic effects offer a unique treatment approach

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None