NCT03885895

Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.

Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA).

Detailed description

One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months. The other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at. The sessions of TXA will be every 2 weeks for 2 months. Postoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations. Follow up after treatment monthly for 2 month.

Conditions

• Therapeutic Efficacy

Interventions

Type	Name	Description
DRUG	Tranexamic Acid Injectable Product	Ampoules used for intradermal injection
DEVICE	Q switched KTP (532nm)	LASER

Timeline

• Start date: 2019-01-15
• Primary completion: 2019-08-01
• Completion: 2019-12-01
• First posted: 2019-03-22
• Last updated: 2019-03-22

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study