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Assessment of Efficacy and Safety of Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid in the Treatment of Melasma: A Randomized Split-Face Study

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Melasma is a chronic acquired hyperpigmentation disorder that commonly affects the face and has a significant impact on quality of life. Available treatments may improve pigmentation, but relapse is common and response can be variable. This randomized split-face interventional study aims to compare the efficacy and safety of injectable platelet-rich fibrin (i-PRF) versus intradermal tranexamic acid (TA) in the treatment of facial melasma. Adult female patients with bilateral symmetrical facial melasma will be enrolled. In each participant, one side of the face will be randomly assigned to receive i-PRF and the contralateral side will receive intradermal TA. Patients will undergo five treatment sessions at 2-week intervals. Clinical response will be assessed using the modified Melasma Area and Severity Index (mMASI), Antera 3D camera measurements, Physician Global Assessment, patient satisfaction, and Melasma Quality of Life (MelasQoL) questionnaire. Safety will be evaluated by recording adverse events such as pain, tenderness, erythema, swelling, infection, ecchymosis, and hematoma. The study is designed to determine whether i-PRF is an effective and safe treatment option for melasma compared with intradermal tranexamic acid.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Clinical diagnosis of bilateral symmetrical facial melasma (epidermal or mixed type)

• Female participants aged 18 to 50 years

• Fitzpatrick skin types III to IV

• Mild to moderate facial melasma

• No melasma-specific treatment within the previous 4 weeks

• No facial procedures, including peeling, laser resurfacing, or microneedling, within the previous 3 months

• Willing and able to provide written informed consent and comply with study procedures

Locations
Other Locations
Egypt
Kasr El Aini Hospital
RECRUITING
Cairo
Contact Information
Primary
Heba Ahmed
heba.a.abdelgayed@kasralainy.edu.eg
+201016532351
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 21
Treatments
Experimental: Injectable Platelet-Rich Fibrin Side
In this randomized split-face study, one side of each participant's face is randomly assigned to receive injectable platelet-rich fibrin (i-PRF). i-PRF is prepared from autologous venous blood and injected intradermally on the assigned side after topical anesthetic. Participants receive 5 treatment sessions at 2-week intervals.
Active_comparator: Intradermal Tranexamic Acid Side
In this randomized split-face study, the contralateral side of each participant's face receives intradermal tranexamic acid after topical anesthetic. Tranexamic acid is prepared under aseptic conditions and injected intradermally into melasma lesions. Participants receive 5 treatment sessions at 2-week intervals.
Related Therapeutic Areas
Sponsors
Leads: Kasr El Aini Hospital

This content was sourced from clinicaltrials.gov