An interventional study of Tranexamic Acid - topical and Microneedling with Topical Tranexamic acid in Female, With and Facial, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
This randomized controlled trial aims to compare different therapeutic approaches for the treatment of melasma.
Participants will be randomly allocated into three treatment groups receiving modified Kligman formula, microneedling-assisted topical tranexamic acid, or nanotechnology-based topical tranexamic acid.
The study will compare these treatment approaches over a defined treatment period followed by a follow-up period.
The study will provide evidence regarding the comparative efficacy and safety of these therapeutic modalities in patients with melasma.
220 studies on the registry are indexed under Facies; 37 are open to participants now.
This study's planned enrollment of 75 is above the median of 40 across 163 interventional studies indexed under Facies.
Browse Facies studies →Sohag University is the lead sponsor of 1,218 studies on the registry; 627 are open to participants now.
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Exclusion Criteria:
Group A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day
Drug: Tranexamic Acid - topical
Group B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin
Procedure: Microneedling with Topical Tranexamic acid
Group C: will use modified Kligman formula every night
Drug: Modified Kligman's Formula
Group A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day. Nanotechnology based formulations are able to overcome skin barrier so the drug will be retained in the epidermis to target melanocytes
Also known as: Nanotechnology-based Tranexamic Acid
Group B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin
Also known as: Microneedling-assisted topical TXA
Group C: will use modified Kligman formula every night.
Change in Melasma Area and Severity Index (MASI) score from baseline to the end of the treatment period
The mean change in MASI score from baseline to the end of the treatment period (4 months) will be compared among the three treatment groups.
Time frame: 4 months after initiation of treatment
Percentage change in Melasma Area and Severity Index (MASI) from baseline to the end of treatment
The percentage change in MASI score from Baseline to the end of the treatment period will be calculated for each participant and compared among the three treatment groups.
Time frame: 4 months after initiation of treatment
Patient Satisfaction assessed using a 4-point patient satisfaction scale
Patient satisfaction with treatment results will be assessed at the end of the treatment period using a 4-point scale: excellent(\>75% improvement), good(51-75% improvement), fair (26-50% improvement), and poor (0-25% improvement).
Time frame: 4 months after initiation of treatment
Incidence of treatment-related adverse events
Treatment safety will be assessed by recording the incidence and types of adverse events, including erythema, irritation, burning, dryness and post-inflammatory hyperpigmentation
Time frame: from initiation of treatment to the end of the treatment period(4months)
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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