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

Phase 1

• Conditions: Therapeutic Efficacy
• Interventions: Drug: Tranexamic Acid Injectable Product; Device: Q switched KTP (532nm)

• Registration Number: NCT03885895
• Lead Sponsor: Kasr El Aini Hospital

Brief 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.

Study Timeline

• Study Start: 2019-01-15
• Status Verified: 2019-03
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Study First Posted: 2019-03-22
• Last Update Posted: 2019-03-22
• Primary Completion: 2019-08
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Both genders
• Age group > 18years old.

Exclusion Criteria

• Pregnant and lactating females.
• Keloid and scarring tendancy
• Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.
• Oral Isotretinoin 6 months prior to the study.
• Active herpetic lesions.
• Any concurrent active skin disease within the treated area.
• Photosensitive skin conditions such as systemic lupus erythematous.
• History of delayed wound healing.
• Bleeding diathesis.
• Medical conditions such as autoimmune diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Participants with freckles (one side of the face)	Tranexamic Acid Injectable Product	one randomized side of the face will be treated by Intradermal Tranexamic acid
Participants with freckles (other side of the face)	Q switched KTP (532nm)	other side will be treated by Q switched KTP laser

Primary Outcome Measures

Name	Time	Method
Pigmentation and severity index by clinical evaluation	6 months to 1 year	Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Melanin Index change by spectrophotometer	6 months to 1 year	Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Blinded observers' evaluation	6 months to 1 year	Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Patient satisfaction rate	6 months to 1 year	Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up

Trial Locations

Locations (1)

Kasr El Ainy university hospital; 🇪🇬 Cairo, Egypt